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Pipeline for Uncoilable or Failed Aneurysms (PUFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00777088
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : September 11, 2018
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Intracranial Aneurysm
Intervention Device: Pipeline Embolization Device (PED)
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pipeline
Hide Arm/Group Description

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

Period Title: Overall Study
Started 108
Completed 107
Not Completed 1
Reason Not Completed
PED Treatment not attempted             1
Arm/Group Title Pipeline
Hide Arm/Group Description

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 Number of Baseline Participants 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
57  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
96
  88.9%
Male
12
  11.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Turkey
18
  16.7%
Hungary
14
  13.0%
United States
76
  70.4%
1.Primary Outcome
Title Number of Participants With the Occurrence of Major Ipsilateral Stroke or Neurologic Death and Occurrence of Ipsilateral Stroke or Neurologic Death.
Hide Description 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.
Time Frame 180-days and 5-years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated with one or more Pipeline Embolization Devices.
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
180-Days
6
   5.6%
5-Years
10
   9.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pipeline
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments The cumulative rate of ipsilateral stroke or neurologic death is not ≥ 20% at 180-day clinical follow-up and the cumulative rate of ipsilateral stroke or neurovascular death is not ≥ 25% at 5-year clinical follow-up
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Bayesian
Comments [Not Specified]
2.Primary Outcome
Title Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) Without Major Parent Artery Stenosis.
Hide Description

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

Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 104 participants and 106 intracranial aneurysms treated with the Pipeline Embolization Device were included in the primary effectiveness endpoint analysis.
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 104
Overall Number of Units Analyzed
Type of Units Analyzed: Fully Occluded Intracranial Aneurysms
106
Count of Units
Unit of Measure: Fully Occluded Intracranial Aneurysms
78
  73.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pipeline
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The rate of complete IA occlusion without major parent artery stenosis exceeds 50% with a posterior probability >0.975.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Bayesian
Comments [Not Specified]
3.Secondary Outcome
Title Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 1 Year
Hide Description

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

Time Frame 1 Year
Hide Outcome Measure Data
Hide Analysis Population Description
Pipeline treated subjects with observable data at 1 year
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 91
Overall Number of Units Analyzed
Type of Units Analyzed: Target Intracranial Aneurysms
91
Count of Units
Unit of Measure: Target Intracranial Aneurysms
79
  86.8%
4.Secondary Outcome
Title Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 3 Year Follow-up
Hide Description

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

Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pipeline treated Subjects with observable data at 3 years
Arm/Group Title Pipeline
Hide Arm/Group Description:
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 Number of Participants Analyzed 76
Overall Number of Units Analyzed
Type of Units Analyzed: Target Intracranial Aneurysms
76
Count of Units
Unit of Measure: Target Intracranial Aneurysms
71
  93.4%
5.Secondary Outcome
Title Count of Intracranial Aneurysms (IA) Evaluated as Completely Occluded (100%) at 5 Years
Hide Description

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

Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pipeline treated subjects with observable data at 5 years
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 62
Overall Number of Units Analyzed
Type of Units Analyzed: Target Intracranial Aneurysms
62
Count of Units
Unit of Measure: Target Intracranial Aneurysms
59
  95.2%
6.Secondary Outcome
Title Stenosis of the Parent Artery in PED at 3 Years
Hide Description Parent artery stenosis (narrowing of the artery from which the aneurysm arises) at 3-year follow-up
Time Frame 3-years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed imaging at the 3-year follow-up were included in the parent artery stenosis analysis.
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 85
Overall Number of Units Analyzed
Type of Units Analyzed: Parent Artery Assessments
85
Count of Units
Unit of Measure: Parent Artery Assessments
Stenosis 0 - 25%
67
  78.8%
Stenosis > 25 - 50%
8
   9.4%
Stenosis >50% - 75%
0
   0.0%
Stenosis >75%
3
   3.5%
Indeterminate
7
   8.2%
7.Secondary Outcome
Title Stenosis of the Parent Artery in PED at 5 Years
Hide Description Parent artery stenosis at 5-year follow-up
Time Frame 5-years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that completed imaging at the 5-year follow-up were included in the parent artery stenosis analysis.
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 64
Overall Number of Units Analyzed
Type of Units Analyzed: Parent Artery Assessments
64
Count of Units
Unit of Measure: Parent Artery Assessments
Stenosis 0 - 25%
50
  78.1%
Stenosis >25 - 50%
3
   4.7%
Stenosis >50 - 75%
1
   1.6%
Stenosis >75%
2
   3.1%
Indeterminate
8
  12.5%
8.Secondary Outcome
Title Number of Participants With Device-Related Adverse Events at 3 Years
Hide Description Number of participants with incidence of device-related adverse events at 3 year follow-up
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
4
   3.7%
9.Secondary Outcome
Title Number of Participants With Device-related Adverse Events at 5 Years
Hide Description Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects Observed with Device Related Adverse Events 5 years after Pipeline Placement
Arm/Group Title Pipeline
Hide Arm/Group Description:

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 Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.9%
Time Frame Cumulative incidence rate of adverse events observed at 5 years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pipeline
Hide Arm/Group Description

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

All-Cause Mortality
Pipeline
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Pipeline
Affected / at Risk (%) # Events
Total   55/107 (51.40%)    
Blood and lymphatic system disorders   
Bone marrow failure  1  1/107 (0.93%)  1
Cardiac disorders   
Atrial fibrillation  1  2/107 (1.87%)  2
Bradycardia  1  2/107 (1.87%)  2
Arrhythmia  1  1/107 (0.93%)  1
Myocardial infarction  1  1/107 (0.93%)  1
Ventricular fibrillation  1  1/107 (0.93%)  1
Wolff-parkinson white syndrome  1  1/107 (0.93%)  1
Ear and labyrinth disorders   
Tinnitus  1  1/107 (0.93%)  1
Endocrine disorders   
Hypothyroidism  1  3/107 (2.80%)  3
Eye disorders   
Amaurosis fugax  1  3/107 (2.80%)  3
Ophthalmoplegia  1  2/107 (1.87%)  2
Retinal artery embolism  1  1/107 (0.93%)  1
Vision blurred  1  1/107 (0.93%)  1
Visual impairment  1  1/107 (0.93%)  1
Gastrointestinal disorders   
Colitis  1  1/107 (0.93%)  1
Diverticulitis intestinal haemorrhagic  1  1/107 (0.93%)  1
Gastrointestinal haemorrhage  1  1/107 (0.93%)  1
Intra-abdominal haemorrhage  1  1/107 (0.93%)  1
Nausea  1  1/107 (0.93%)  1
Oesophageal spasm  1  1/107 (0.93%)  1
Rectal haemorrhage  1  1/107 (0.93%)  1
Retroperitoneal haematoma  1  1/107 (0.93%)  1
General disorders   
Catheter site discharge  1  1/107 (0.93%)  1
Death  1  1/107 (0.93%)  1
Infections and infestations   
Abdominal abscess  1  1/107 (0.93%)  1
Cholecystitis infective  1  1/107 (0.93%)  1
Pneumonia  1  1/107 (0.93%)  1
Upper respiratory tract infection  1  1/107 (0.93%)  1
Injury, poisoning and procedural complications   
Ankle fracture  1  1/107 (0.93%)  1
Arterial injury  1  1/107 (0.93%)  1
Hip fracture  1  1/107 (0.93%)  1
Joint injury  1  1/107 (0.93%)  1
Procedural haemorrhage  1  1/107 (0.93%)  1
Road traffic accident  1  1/107 (0.93%)  1
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/107 (0.93%)  1
Intervertebral disk degeneration  1  1/107 (0.93%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Adenocarcinoma  1  1/107 (0.93%)  1
Breast cancer  1  1/107 (0.93%)  1
Creast cancer recurrent  1  1/107 (0.93%)  1
Lung neoplasm  1  1/107 (0.93%)  1
Prostate cancer  1  1/107 (0.93%)  1
Nervous system disorders   
Cerebral Haemorrhage * 1  6/107 (5.61%)  6
Headcahe  1  6/107 (5.61%)  6
Cerebral Ischaemia  1  3/107 (2.80%)  3
Liird nerve disorder  1  2/107 (1.87%)  2
Ischaemia stroke  1  2/107 (1.87%)  2
Syncope  1  2/107 (1.87%)  2
Carotid artery occlusion  1  1/107 (0.93%)  1
Carpal tunnel syndrome  1  1/107 (0.93%)  1
Cerebral artery embolism  1  1/107 (0.93%)  1
Dimentia alzheimer's type  1  1/107 (0.93%)  1
Dizziness  1  1/107 (0.93%)  1
Hemiparesis  1  1/107 (0.93%)  1
Vith nerve disorder  1  1/107 (0.93%)  1
Psychiatric disorders   
Depression  1  1/107 (0.93%)  1
Renal and urinary disorders   
Haematuria  1  1/107 (0.93%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  2/107 (1.87%)  2
Emphysema  1  1/107 (0.93%)  1
Haemoptysis  1  1/107 (0.93%)  1
Pulmonary embolism  1  1/107 (0.93%)  1
Surgical and medical procedures   
Aneurysm repair  1  3/107 (2.80%)  3
Arterial aneurysm repair  1  1/107 (0.93%)  1
Intra-cerebral aneurysm repair  1  1/107 (0.93%)  1
Knee arthroplasty  1  1/107 (0.93%)  1
Vascular disorders   
Aneurysm  1  1/107 (0.93%)  1
Deep vein thrombosis  1  1/107 (0.93%)  1
Embolism  1  1/107 (0.93%)  1
Haematoma  1  1/107 (0.93%)  1
Hypotension  1  1/107 (0.93%)  1
Intermittent claudification  1  1/107 (0.93%)  1
Peripheral vascular disorder  1  1/107 (0.93%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Pipeline
Affected / at Risk (%) # Events
Total   74/107 (69.16%)    
Eye disorders   
Visual Impairment  1  13/107 (12.15%)  13
Gastrointestinal disorders   
Nausea  1  12/107 (11.21%)  12
Infections and infestations   
Infection  1  6/107 (5.61%)  6
Nervous system disorders   
Headache  1  34/107 (31.78%)  34
Dizziness  1  6/107 (5.61%)  6
Paraesthesia  1  3/107 (2.80%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Darren LaCour
Organization: Medtronic
Phone: 949-680-1274
EMail: darren.j.lacour@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT00777088    
Other Study ID Numbers: COVPUFS0398
First Submitted: October 20, 2008
First Posted: October 22, 2008
Results First Submitted: March 7, 2018
Results First Posted: September 11, 2018
Last Update Posted: November 20, 2018