Trial Outcomes & Findings for Pipeline for Uncoilable or Failed Aneurysms (NCT NCT00777088)

Last Updated: 2018-11-20

Results Overview

The number of participants with occurrence of major ipsilateral stroke or neurologic death after PED placement at 180-days and the occurrence of ipsilateral stroke or neurologic death after Pipeline Embolization Devices (PED) placement at 5-years.

Recruitment status

COMPLETED

Study phase

Target enrollment

108 participants

Primary outcome timeframe

180-days and 5-years

Results posted on

2018-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Pipeline Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Overall Study STARTED	108
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pipeline Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Overall Study PED Treatment not attempted	1

Baseline Characteristics

Pipeline for Uncoilable or Failed Aneurysms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pipeline n=108 Participants Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Age, Continuous	57 Years STANDARD_DEVIATION 11.3 • n=99 Participants
Sex: Female, Male Female	96 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment Turkey	18 Participants n=99 Participants
Region of Enrollment Hungary	14 Participants n=99 Participants
Region of Enrollment United States	76 Participants n=99 Participants

PRIMARY outcome

Timeframe: 180-days and 5-years

Population: Patients treated with one or more Pipeline Embolization Devices.

Outcome measures

Outcome measures
Measure	Pipeline n=107 Participants Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. 180-Days	6 Participants
Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death. 5-Years	10 Participants

PRIMARY outcome

Timeframe: 180 days

Population: A total of 104 participants and 106 intracranial aneurysms treated with the Pipeline Embolization Device were included in the primary effectiveness endpoint analysis.

The count of Intracranial Aneurysms (IA) evaluated as completely occluded (defined as Raymond Grade 1) without major parent artery stenosis at 180 days. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac

Outcome measures

Outcome measures
Measure	Pipeline n=106 Fully Occluded Intracranial Aneurysms Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.	78 Fully Occluded Intracranial Aneurysms

SECONDARY outcome

Timeframe: 1 Year

Population: Pipeline treated subjects with observable data at 1 year

The count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) (defined as Raymond-Roy grade 1) 1 year follow-up visit. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac

Outcome measures

Outcome measures
Measure	Pipeline n=91 Target Intracranial Aneurysms Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year	79 Target Intracranial Aneurysms

SECONDARY outcome

Timeframe: 3 years

Population: Pipeline treated Subjects with observable data at 3 years

The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 3 year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac

Outcome measures

Outcome measures
Measure	Pipeline n=76 Target Intracranial Aneurysms Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up	71 Target Intracranial Aneurysms

SECONDARY outcome

Timeframe: 5 years

Population: Pipeline treated subjects with observable data at 5 years

The count of Intracranial Aneurysms (IA) evaluated as completely occluded (100%) (defined as Raymond-Roy grade 1) at 5-year follow-up. The Raymond-Roy Grade scale measures the amount of visual contrast flow throughout the aneurysm anatomy. The Raymond-Roy aneurysm occlusion scale is follows: Complete = complete occlusion, no flow of contrast seen in the sac Residual Neck = partial occlusion, some flow, or eddying flow, in the sac Residual Aneurysm = incomplete occlusion, apparent flow into the sac

Outcome measures

Outcome measures
Measure	Pipeline n=62 Target Intracranial Aneurysms Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years	59 Target Intracranial Aneurysms

SECONDARY outcome

Timeframe: 3-years

Population: Subjects that completed imaging at the 3-year follow-up were included in the parent artery stenosis analysis.

Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up

Outcome measures

Outcome measures
Measure	Pipeline n=85 Parent Artery Assessments Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Stenosis of the Parent Artery in PED at 3 Years Stenosis 0 - 25%	67 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 3 Years Stenosis > 25 - 50%	8 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 3 Years Stenosis >50% - 75%	0 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 3 Years Stenosis >75%	3 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 3 Years Indeterminate	7 Parent Artery Assessments

SECONDARY outcome

Timeframe: 5-years

Population: Subjects that completed imaging at the 5-year follow-up were included in the parent artery stenosis analysis.

Parent artery stenosis at 5-year follow-up

Outcome measures

Outcome measures
Measure	Pipeline n=64 Parent Artery Assessments Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Stenosis of the Parent Artery in PED at 5 Years Stenosis >25 - 50%	3 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 5 Years Stenosis >50 - 75%	1 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 5 Years Stenosis >75%	2 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 5 Years Indeterminate	8 Parent Artery Assessments
Stenosis of the Parent Artery in PED at 5 Years Stenosis 0 - 25%	50 Parent Artery Assessments

SECONDARY outcome

Timeframe: 3 years

Number of participants with incidence of device-related adverse events at 3 year follow-up

Outcome measures

Outcome measures
Measure	Pipeline n=107 Participants Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Number of Participants With Device-Related Adverse Events at 3 Years	4 Participants

SECONDARY outcome

Timeframe: 5 years

Population: Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement

Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement

Outcome measures

Outcome measures
Measure	Pipeline n=107 Participants Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Number of Participants With Device-related Adverse Events at 5 Years	2 Participants

Adverse Events

Pipeline

Serious events: 55 serious events

Other events: 74 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pipeline n=107 participants at risk Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Nervous system disorders Cerebral Haemorrhage	5.6% 6/107 • Number of events 6 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Headcahe	5.6% 6/107 • Number of events 6 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Cerebral Ischaemia	2.8% 3/107 • Number of events 3 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Liird nerve disorder	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Ischaemia stroke	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Syncope	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Carotid artery occlusion	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Carpal tunnel syndrome	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Cerebral artery embolism	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Dimentia alzheimer's type	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Dizziness	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Hemiparesis	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Vith nerve disorder	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Cardiac disorders Atrial fibrillation	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Cardiac disorders Bradycardia	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Cardiac disorders Arrhythmia	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Cardiac disorders Myocardial infarction	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Cardiac disorders Ventricular fibrillation	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Cardiac disorders Wolff-parkinson white syndrome	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Eye disorders Amaurosis fugax	2.8% 3/107 • Number of events 3 • Cumulative incidence rate of adverse events observed at 5 years.
Eye disorders Ophthalmoplegia	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Eye disorders Retinal artery embolism	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Eye disorders Vision blurred	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Eye disorders Visual impairment	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Colitis	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Diverticulitis intestinal haemorrhagic	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Nausea	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Oesophageal spasm	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Rectal haemorrhage	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Retroperitoneal haematoma	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Aneurysm	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Deep vein thrombosis	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Embolism	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Haematoma	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Hypotension	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Intermittent claudification	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Vascular disorders Peripheral vascular disorder	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Injury, poisoning and procedural complications Ankle fracture	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Injury, poisoning and procedural complications Arterial injury	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Injury, poisoning and procedural complications Hip fracture	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Injury, poisoning and procedural complications Joint injury	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Injury, poisoning and procedural complications Procedural haemorrhage	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Injury, poisoning and procedural complications Road traffic accident	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Surgical and medical procedures Aneurysm repair	2.8% 3/107 • Number of events 3 • Cumulative incidence rate of adverse events observed at 5 years.
Surgical and medical procedures Arterial aneurysm repair	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Surgical and medical procedures Intra-cerebral aneurysm repair	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Surgical and medical procedures Knee arthroplasty	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.9% 2/107 • Number of events 2 • Cumulative incidence rate of adverse events observed at 5 years.
Respiratory, thoracic and mediastinal disorders Emphysema	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Infections and infestations Abdominal abscess	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Infections and infestations Cholecystitis infective	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Infections and infestations Pneumonia	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Infections and infestations Upper respiratory tract infection	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Creast cancer recurrent	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Endocrine disorders Hypothyroidism	2.8% 3/107 • Number of events 3 • Cumulative incidence rate of adverse events observed at 5 years.
General disorders Catheter site discharge	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
General disorders Death	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Musculoskeletal and connective tissue disorders Arthritis	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Musculoskeletal and connective tissue disorders Intervertebral disk degeneration	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Blood and lymphatic system disorders Bone marrow failure	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Ear and labyrinth disorders Tinnitus	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Psychiatric disorders Depression	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.
Renal and urinary disorders Haematuria	0.93% 1/107 • Number of events 1 • Cumulative incidence rate of adverse events observed at 5 years.

Other adverse events

Other adverse events
Measure	Pipeline n=107 participants at risk Placement of Pipeline Embolization Device in the parent artery at the aneurysm location Pipeline Embolization Device (PED): 1 or more PEDs placed in the parent artery of the affected aneurysm via endovascular approach
Nervous system disorders Headache	31.8% 34/107 • Number of events 34 • Cumulative incidence rate of adverse events observed at 5 years.
Eye disorders Visual Impairment	12.1% 13/107 • Number of events 13 • Cumulative incidence rate of adverse events observed at 5 years.
Gastrointestinal disorders Nausea	11.2% 12/107 • Number of events 12 • Cumulative incidence rate of adverse events observed at 5 years.
Infections and infestations Infection	5.6% 6/107 • Number of events 6 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Dizziness	5.6% 6/107 • Number of events 6 • Cumulative incidence rate of adverse events observed at 5 years.
Nervous system disorders Paraesthesia	2.8% 3/107 • Number of events 3 • Cumulative incidence rate of adverse events observed at 5 years.

Additional Information

Darren LaCour

Medtronic

Phone: 949-680-1274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place