Trial Outcomes & Findings for Pipeline Flex With SHield Technology Embolization - An International MulticEnter ObservationaL Post Market StuDy (NCT NCT02719522)
NCT ID: NCT02719522
Last Updated: 2022-01-11
Results Overview
Percentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year)
Recruitment status
COMPLETED
Target enrollment
205 participants
Primary outcome timeframe
1 year
Results posted on
2022-01-11
Participant Flow
Patients have been enrolled in 21 sites in EU, Australia and Israel between 24-Mar-2016 and 27-Sep-2017.
Participant milestones
| Measure |
Intention to Treat (ITT)
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Overall Study
STARTED
|
204
|
|
Overall Study
COMPLETED
|
193
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Intention to Treat (ITT)
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Overall Study
Implant Failure
|
4
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intention to Treat (ITT)
n=204 Participants
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 12.81 • n=204 Participants
|
|
Age, Customized
≤60 years
|
134 Participants
n=204 Participants
|
|
Age, Customized
> 60 years
|
70 Participants
n=204 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=204 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=204 Participants
|
|
Region of Enrollment
Greece
|
21 participants
n=204 Participants
|
|
Region of Enrollment
Hungary
|
5 participants
n=204 Participants
|
|
Region of Enrollment
Finland
|
9 participants
n=204 Participants
|
|
Region of Enrollment
Denmark
|
3 participants
n=204 Participants
|
|
Region of Enrollment
Italy
|
26 participants
n=204 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=204 Participants
|
|
Region of Enrollment
Israel
|
5 participants
n=204 Participants
|
|
Region of Enrollment
Australia
|
30 participants
n=204 Participants
|
|
Region of Enrollment
France
|
1 participants
n=204 Participants
|
|
Region of Enrollment
Germany
|
23 participants
n=204 Participants
|
|
Region of Enrollment
Spain
|
54 participants
n=204 Participants
|
PRIMARY outcome
Timeframe: 1 yearPercentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death post-procedure (1-year)
Outcome measures
| Measure |
Intention to Treat (ITT)
n=204 Participants
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Safety - Stroke/Death Occurrence
|
3.23 percentage of patients with event
Interval 1.27 to 6.68
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Primary effectiveness endpoint was analyzed specifically on subjects with successful device implantation (FAS population, N=200).
Percentage (%) of Participants who have achieved complete aneurysm occlusion (defined as Raymond-Roy grade 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm post-procedure (1-year)
Outcome measures
| Measure |
Intention to Treat (ITT)
n=200 Participants
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Effectiveness - Aneurysm Occlusion
|
71.67 percentage of patients
Interval 64.95 to 77.74
|
SECONDARY outcome
Timeframe: 30 daysPercentage (%) of Participants who experienced a major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure due to procedural complications
Outcome measures
| Measure |
Intention to Treat (ITT)
n=204 Participants
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Safety - Stroke/Death Occurrence - 30 Days
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage (%) of Participants who experienced a delayed intracerebral hemorrhage \> 30 days post-procedure
Outcome measures
| Measure |
Intention to Treat (ITT)
n=204 Participants
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Safety - Intracerebral Hemorrhage (ICH)
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPercentage (%) of Participants who have had a successful deployment of the device at the target site. A device is considered properly deployed when it covers the entire length of the aneurysm neck.
Outcome measures
| Measure |
Intention to Treat (ITT)
n=204 Participants
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Effectiveness - Deployment Rate
|
200 Participants
|
Adverse Events
Intention to Treat (ITT)
Serious events: 44 serious events
Other events: 74 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Intention to Treat (ITT)
n=204 participants at risk
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Eye disorders
Retinal artery occlusion
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Eye disorders
Visual impairment
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral infarction
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral microembolism
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Intracranial mass
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Ischaemic stroke
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Surgical and medical procedures
Aneurysm repair
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
General disorders
Chest pain
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
General disorders
Pyrexia
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Infections and infestations
Haematoma infection
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Infections and infestations
Infection
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Infections and infestations
Wound infection
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral vasoconstriction
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cranial nerve palsies multiple
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Dysaesthesia
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Headache
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Renal and urinary disorders
Renal failure
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Vascular disorders
Embolism venous
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Vascular disorders
Vasospasm
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
Other adverse events
| Measure |
Intention to Treat (ITT)
n=204 participants at risk
Includes all consented subjects in whom deployment of the Pipeline™ Shield device was attempted. For the ITT population, primary effectiveness endpoint analysis was based on Full Analysis Set (FAS) population and safety analysis was based on the ITT population.
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Eye disorders
Eye pain
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Eye disorders
Photopsia
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Eye disorders
Vision blurred
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Eye disorders
Visual impairment
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Gastrointestinal disorders
Nausea
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
General disorders
Catheter site pain
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
General disorders
Vascular stent stenosis
|
7.8%
16/204 • Number of events 16 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.9%
6/204 • Number of events 6 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
2.9%
6/204 • Number of events 6 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
2.9%
6/204 • Number of events 6 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular access site pseudoaneurysm
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Amnesia
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Cerebral infarction
|
2.0%
4/204 • Number of events 4 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Dysaesthesia
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Headache
|
5.4%
11/204 • Number of events 11 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Hypoaesthesia
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Lacunar infarction
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Nervous system disorder
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Paraesthesia
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Polyneuropathy
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Tension headache
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
3/204 • Number of events 3 • Adverse Events have been collected through 1 year from study procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haematoma
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Vascular disorders
Haematoma
|
0.49%
1/204 • Number of events 1 • Adverse Events have been collected through 1 year from study procedure.
|
|
Vascular disorders
Vascular wall hypertrophy
|
0.98%
2/204 • Number of events 2 • Adverse Events have been collected through 1 year from study procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place