Trial Outcomes & Findings for DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study (NCT NCT01321073)
NCT ID: NCT01321073
Last Updated: 2026-01-26
Results Overview
A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
64 participants
Primary outcome timeframe
Implant to 2 years
Results posted on
2026-01-26
Participant Flow
Participant milestones
| Measure |
DelIVery for Pulmonary Arterial Hypertension Single Arm
All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
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|---|---|
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Overall Study
STARTED
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64
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Overall Study
COMPLETED
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57
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
DelIVery for Pulmonary Arterial Hypertension Single Arm
All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
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|---|---|
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Overall Study
Did not attempt implant
|
4
|
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Overall Study
Death
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3
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Baseline Characteristics
DelIVery for Pulmonary Arterial Hypertension (PAH) & Continued Support Study
Baseline characteristics by cohort
| Measure |
DelIVery for Pulmonary Arterial Hypertension Single Arm
n=60 Participants
All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
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|---|---|
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Age, Continuous
|
50.1 years
STANDARD_DEVIATION 13.5 • n=41 Participants
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Sex: Female, Male
Female
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48 Participants
n=41 Participants
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Sex: Female, Male
Male
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12 Participants
n=41 Participants
|
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Race/Ethnicity, Customized
Asian
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2 Participants
n=41 Participants
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Race/Ethnicity, Customized
Black or African American
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3 Participants
n=41 Participants
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Race/Ethnicity, Customized
Hispanic or Latino
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8 Participants
n=41 Participants
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Race/Ethnicity, Customized
White or Caucasian
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47 Participants
n=41 Participants
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Region of Enrollment
United States
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60 Participants
n=41 Participants
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PRIMARY outcome
Timeframe: Implant to 2 yearsPopulation: All days of follow-up for implanted patients
A complication is an adverse event that required an invasive intervention. Complications related to the implanted catheter are counted. In addition, because pneumothoraxes are counted as part of the endpoint.
Outcome measures
| Measure |
DelIVery for Pulmonary Arterial Hypertension Single Arm
n=22013 Patient days
All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
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|---|---|
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Rate of Catheter-related Complications Per 1000 Patient Days
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0.27 complications per 1000 patient-days
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Adverse Events
Single Arm
Serious events: 29 serious events
Other events: 57 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Single Arm
n=60 participants at risk
All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
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|---|---|
|
Nervous system disorders
Syncope
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
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Blood and lymphatic system disorders
Anaemia
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Blood and lymphatic system disorders
Autoimmune thrombocytopenia
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Cardiac disorders
Angina unstable
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Cardiac disorders
Atrial fibrillation
|
3.3%
2/60 • Number of events 2 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
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|
Cardiac disorders
Atrial flutter
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Cardiac disorders
Cardiac failure
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Cardiac disorders
Pericardial effusion
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
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|
Cardiac disorders
Right ventricular failure
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
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General disorders
Device damage
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Device dislocation
|
3.3%
2/60 • Number of events 3 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
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General disorders
Immediate post-injection reaction
|
5.0%
3/60 • Number of events 3 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Implant site effusion
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1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Injection site reaction
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Implant site infection
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Lobar pneumonia
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1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Lyme disease
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • Number of events 2 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Pneumonia legionella
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Rhinovirus infection
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Septic shock
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Urinary tract infection
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Metabolism and nutrition disorders
Fluid overload
|
3.3%
2/60 • Number of events 2 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Metabolism and nutrition disorders
Gout
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Renal and urinary disorders
Renal failure
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Renal and urinary disorders
Renal failure chronic
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Reproductive system and breast disorders
Endometriosis
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.3%
2/60 • Number of events 2 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • Number of events 2 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Vascular disorders
Venous stenosis
|
1.7%
1/60 • Number of events 1 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
Other adverse events
| Measure |
Single Arm
n=60 participants at risk
All subjects were enrolled for implantation of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection.
Model 10642 Implantable Intravascular Catheter: This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
6/60 • Number of events 6 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
5/60 • Number of events 5 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Gastrointestinal disorders
Nausea
|
18.3%
11/60 • Number of events 11 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Fatigue
|
10.0%
6/60 • Number of events 6 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Implant site bruising
|
16.7%
10/60 • Number of events 10 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Implant site pain
|
85.0%
51/60 • Number of events 54 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Injection site pain
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
General disorders
Injection site reaction
|
15.0%
9/60 • Number of events 10 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.3%
17/60 • Number of events 21 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60 • Number of events 6 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
4/60 • Number of events 4 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.7%
7/60 • Number of events 7 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Nervous system disorders
Dizziness
|
11.7%
7/60 • Number of events 7 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Nervous system disorders
Headache
|
13.3%
8/60 • Number of events 10 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Psychiatric disorders
Insomnia
|
8.3%
5/60 • Number of events 5 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
10/60 • Number of events 16 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
5/60 • Number of events 5 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
13.3%
8/60 • Number of events 9 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Vascular disorders
Flushing
|
8.3%
5/60 • Number of events 5 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
|
Vascular disorders
Hypotension
|
15.0%
9/60 • Number of events 9 • Implant to 24 months
An adverse event is any untoward medical occurrence in a subject. Serious Adverse Events include adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, a persistent or significant disability/incapacity or a congenital anomaly/birth defect. Other important medical events, based upon medical judgment, may also be considered serious if a trial participants' health is at risk and intervention is required.
|
Additional Information
Robert Bourge, M.D., Professor of Medicine, Radiology, and Surgery
The University of Alabama at Birmingham
Phone: (205)934-7400
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60