Trial Outcomes & Findings for XIENCE Skypoint Large Vessel Post Approval Study (NCT NCT05423379)
NCT ID: NCT05423379
Last Updated: 2026-02-24
Results Overview
TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR).
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
102 participants
Primary outcome timeframe
At 1 Year
Results posted on
2026-02-24
Participant Flow
The study registered a total of 102 subjects at 18 investigational sites on September 14, 2022 to November 8, 2023. and all active subjects enrolled completed their 12-month follow-up.
Participant milestones
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
5
|
|
Overall Study
Other reasons
|
1
|
Baseline Characteristics
XIENCE Skypoint Large Vessel Post Approval Study
Baseline characteristics by cohort
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
n=102 Participants
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Sex: Female, Male
Male
|
79 Participants
n=58 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 10.4 • n=58 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=58 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
26 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
69 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
Declined or unable to disclose due to local regulation
|
25 Participants
n=58 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 Participants
n=58 Participants
|
|
Hyperlipidemia
|
76 Participants
n=58 Participants
|
|
Hypertension
|
81 Participants
n=58 Participants
|
|
Tobacco use
|
66 Participants
n=58 Participants
|
PRIMARY outcome
Timeframe: At 1 YearPopulation: Analysis population included subjects who provided written informed consent, have at least one XIENCE Skypoint stent diameters 4.5 mm and 5.0 mm implanted, and were confirmed to meet all general/angiographic eligibility criteria at registration.
TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
n=101 Participants
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Descriptive Primary Endpoint: Target Lesion Failure (TLF)
|
8.9 percentage of participants
Interval 4.16 to 16.24
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Analysis population included subjects who provided written informed consent, have at least one XIENCE Skypoint stent diameters 4.5 mm and 5.0 mm implanted, and were confirmed to meet all general/angiographic eligibility criteria at registration.
TLFsp-MI is defined as the composite of CD and TV-MI, including spontaneous MI and excluding periprocedural MI and, or ID-TLR. TLFSCAI is defined as the composite of CD and TV-MI, including both periprocedural MI and spontaneous MI, or ID-TLR.
Outcome measures
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
n=101 Participants
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI)
Target Lesion Failure (TLFsp-MI)
|
5.9 percentage of participants
Interval 2.21 to 12.48
|
|
Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI)
Target Lesion Failure (TLFSCAI)
|
9.9 percentage of participants
Interval 4.85 to 17.46
|
Adverse Events
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
Serious events: 35 serious events
Other events: 80 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
n=102 participants at risk
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Haemorrhage
|
2.9%
3/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Hypertension
|
3.9%
4/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Hypotension
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Angina pectoris
|
4.9%
5/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Arrhythmia
|
2.9%
3/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
4/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Atrial flutter
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.9%
4/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Myocardial infarction
|
2.9%
3/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Palpitations
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Pericardial effusion
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Sinus arrest
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Ear and labyrinth disorders
Vertigo
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Chest discomfort
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Death
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Non-cardiac chest pain
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Perforation
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Vascular stent thrombosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Immune system disorders
Hypersensitivity
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Infections and infestations
Pneumonia
|
4.9%
5/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Investigations
Myocardial necrosis marker increased
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Nervous system disorders
Encephalopathy
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Nervous system disorders
Syncope
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Renal and urinary disorders
Renal failure
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Surgical and medical procedures
Arterial revascularisation
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Surgical and medical procedures
Ligament operation
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Aortic stenosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
Other adverse events
| Measure |
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
n=102 participants at risk
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.
|
|---|---|
|
Cardiac disorders
Coronary artery dissection
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Myocardial infarction
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Nausea
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Chest pain
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Fatigue
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Non-cardiac chest pain
|
7.8%
8/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
General disorders
Oedema peripheral
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Investigations
Myocardial necrosis marker increased
|
65.7%
67/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Haemorrhage
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Hypertension
|
3.9%
4/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Vascular disorders
Hypotension
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.9%
3/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Nervous system disorders
Dizziness
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Nervous system disorders
Encephalopathy
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Psychiatric disorders
Mental status changes
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Reproductive system and breast disorders
Breast mass
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
6/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Surgical and medical procedures
Arterial revascularisation
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Angina pectoris
|
3.9%
4/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Arrhythmia
|
3.9%
4/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
2/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Bradycardia
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.98%
1/102 • 1 year
All site-reported AEs have been coded to standard medical terms using the Medical Dictionary for Regulatory Activities (MedDRA) by Abbott. All AEs entered into the EDC system have been evaluated and categorized by the Abbott Safety Team into main categories and subcategories. Summaries of site-reported events by MedDRA Code through 365 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Inst. may publish data/results individually from its site after any of (1) a multi-center publication is published, (2) no multicenter publication is submitted within 18monthsafter closure of the Study, or (3) Abbott confirms there will be no multi-center publication. Inst. shall provide Sponsor with draft at least 60 days prior to submission for Sponsor review/comment. Upon request, Publication shall be delayed an additional 60 days. Due consideration will be given to Sponsor comments.
- Publication restrictions are in place
Restriction type: OTHER