Back to resultsStudy to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
Primary Purpose
Intracranial Aneurysm
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Aneurysm focused on measuring CODMAN ENTERPRISE® Vascular Reconstruction Device, Wide Neck, Intracranial, Saccular Aneurysms, Cerebral Aneurysms
Eligibility Criteria
Inclusion Criteria:
- Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm
- Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment
- Subject is willing to comply with specified follow-up evaluation
Exclusion Criteria:
- Planned staged procedure
- Currently enrolled in another investigational device or drug study
- Target aneurysm that has been previously treated
- Mycotic, fusiform or dissecting aneurysm
- Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0
- A serum creatinine level > 2.5 mg/dL within 7 days prior to index procedure
Sites / Locations
- Radiology Imaging Associates
- University of Florida
- Lyerly Neurosurgery, an Affiliate of Baptist Health
- University of Illinois at Chicago
- Johns Hopkins University
- University of Massachusetts Medical Center
- University of Buffalo
- Mount Sinai Health System
- Miami Valley Hospital
- Lehigh Valley Health Network
- Inova Fairfax Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enterprise
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Complete Aneurysm Occlusion (RCAO) Without Retreatment at 12-Month Post Procedure
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who were retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure
The incidence of a major ipsilateral stroke and/or death due to ipsilateral stroke was evaluated from the start of the index procedure until completion of the 12-month follow-up. A major ipsilateral stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of greater than or equal to (>=) 4 on the National Institute of Health Stroke Scale (NIHSS) as compared to baseline and persists for greater than 24 hours. The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of >= 4.
Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory
In-stent stenosis is defined as greater than 50 percent (%) narrowing of the vessel within the ENTERPRISE stent or within 10 millimeters (mm) of either end of the stent.
Secondary Outcome Measures
Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months
The procedure success rate is defined to be the percentage of aneurysms in which coil mass position is maintained within the sac with parent artery patency, without additional procedures for treatment of the aneurysm since the index procedure. The procedure success was summarized immediately post-treatment (acute), and at the 6- and 12-month follow-up assessments.
Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Complete/partial aneurysm occlusion is defined as an aneurysm in which a score of 1 (complete occlusion) or 2 (residual neck) is achieved on the Raymond Scale, regardless of retreatment. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month post-procedure follow-up visit was considered not to have achieved complete aneurysm occlusion.
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Number of Participants with aneurysms occlusion of 100%, 90%-99%, 70-89%, 50-69%, 25-49%, or <25% occlusion in accordance with Consensus Grades 0 (100% complete aneurysm occlusion) - 5 (<25% volumetric aneurysm occlusion), respectively, was reported immediately post-procedure (acute), and at the 6 and 12 month follow-up, respectively.
Number of Participants With Aneurysm Recanalization
Number of participants with aneurysm recanalization was reported. Recanalization was defined as an increase in aneurysm filling as compared to the previous study-specified angiographic assessment, resulting in a change in (that is, worsening of) the Raymond classification.
Number of Participants Retreated With Any Additional Treatment
Retreatment was defined as any additional treatment of the target aneurysm after the index procedure (retreatment includes staged procedures), or an additional procedure (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture or bleeding.
Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score
Observed scores on the Modified Ranking Scale was presented at baseline (pre-procedure) and follow-up (30 days, 6 and 12 months post-procedure). mRS score: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities but able to look after own affairs without assistant; 3 = moderate disability, requires some help, but able to walk without assistance; 4 = moderate to severe disability, unable to walk without assistance, and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; 6 = dead. The number of participants who had an increase in mRS > 2 from baseline not related to stroke or death was also be presented for each follow-up time point.
Number of Participants With NIH Stroke Scale (NIHSS) Worsening
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of >= 4.
Number of Participants With Reduced Thrombolysis in Cerebral Infarction (TICI) Flow (New Occurrence of TICI Grade of 0 or 1)
The percentage of target aneurysms in which a new occurrence of unintentional and persistent reduced TICI flow (TICI grade of 0: No perfusion or 1: Partial perfusion) was observed at the target vessel during the index procedure as a result of a mechanical obstruction such as dissection or luminal thrombus was evaluated. TICI evaluates perfusion severity and ranges from Grade 0 (No perfusion) to 3 (Complete perfusion).
Number of Participants With Bleeding Complications
The number of participants who experienced a procedure-related hemorrhagic event which required any of the following was evaluated: blood transfusion, surgical intervention, a new hospitalization, or lengthening of hospital stay. The complications of hematoma requiring treatment (that is, hematoma > 5 centimeter [cm] in diameter occurring at the access site) and retroperitoneal bleeding were reported as hemorrhagic events.
Number of Participants With In-Stent Stenosis Per Independent Core Laboratory During Procedure (Acute), Post-procedure up to 6 Months and 12 Months Follow up
In-stent stenosis is defined as greater than 50% narrowing of the vessel within the ENTERPRISE stent or within 10 mm of either end of the stent.
Number of Participants With Thrombosis Per Independent Core Laboratory
Thrombosis is defined as in-stent thrombosis.
Full Information
NCT ID
NCT02532517
First Posted
August 24, 2015
Last Updated
September 30, 2020
Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02532517
Brief Title
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
Official Title
A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System When Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-necked Saccular Intracranial Aneurysms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
No safety issues; change in innovation strategy
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
September 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
Detailed Description
The study is a prospective, multi-center, single arm, clinical study to evaluate the safety and effectiveness of the ENTERPRISE stent when used in conjunction with endovascular coil embolization in the treatment of unruptured wide-neck, intracranial, saccular anterior circulation aneurysms (≤ 10 mm). The primary objectives of the study are to evaluate the rate of complete angiographic occlusion at 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm
Keywords
CODMAN ENTERPRISE® Vascular Reconstruction Device, Wide Neck, Intracranial, Saccular Aneurysms, Cerebral Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enterprise
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Aneurysm Occlusion (RCAO) Without Retreatment at 12-Month Post Procedure
Description
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who were retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
Time Frame
12 Months Post Procedure
Title
Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure
Description
The incidence of a major ipsilateral stroke and/or death due to ipsilateral stroke was evaluated from the start of the index procedure until completion of the 12-month follow-up. A major ipsilateral stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of greater than or equal to (>=) 4 on the National Institute of Health Stroke Scale (NIHSS) as compared to baseline and persists for greater than 24 hours. The NIHSS is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of >= 4.
Time Frame
At 12 Months Post Procedure
Title
Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory
Description
In-stent stenosis is defined as greater than 50 percent (%) narrowing of the vessel within the ENTERPRISE stent or within 10 millimeters (mm) of either end of the stent.
Time Frame
At 12 Months post procedure
Secondary Outcome Measure Information:
Title
Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months
Description
The procedure success rate is defined to be the percentage of aneurysms in which coil mass position is maintained within the sac with parent artery patency, without additional procedures for treatment of the aneurysm since the index procedure. The procedure success was summarized immediately post-treatment (acute), and at the 6- and 12-month follow-up assessments.
Time Frame
Immediately post-procedure (acute), 6 and 12 months
Title
Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
Description
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. RCAO was assessed by the Independent Core Laboratory, complete aneurysm occlusion is defined as an aneurysm in which a Grade I (completion occlusion), is achieved on the Raymond Scale at the relevant post-procedure angiogram, without additional procedures for treatment of the aneurysm since the index procedure. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month were considered not to have achieved complete aneurysm occlusion.
Time Frame
Immediately post-procedure (acute), 6 and 12 months
Title
Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
Description
The Raymond-Roy Grading scale used for judging intracranial aneurysm (IA) endosaccular embolization success ranges from Grade I to III where, Grade I is completion occlusion with no flow of contrast seen in the aneurysm sac, Grade II is partial occlusion with some flow or eddy flow in the aneurysm sac and Grade III is residual aneurysm or Incomplete occlusion with apparent flow in the aneurysm sac. Complete/partial aneurysm occlusion is defined as an aneurysm in which a score of 1 (complete occlusion) or 2 (residual neck) is achieved on the Raymond Scale, regardless of retreatment. Participants who are retreated (retreatment includes staged procedures) prior to the 12-month post-procedure follow-up visit was considered not to have achieved complete aneurysm occlusion.
Time Frame
Immediately post-procedure (acute), 6 and 12 Months
Title
Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
Description
Number of Participants with aneurysms occlusion of 100%, 90%-99%, 70-89%, 50-69%, 25-49%, or <25% occlusion in accordance with Consensus Grades 0 (100% complete aneurysm occlusion) - 5 (<25% volumetric aneurysm occlusion), respectively, was reported immediately post-procedure (acute), and at the 6 and 12 month follow-up, respectively.
Time Frame
Immediately post-procedure (acute), 6 and 12 months
Title
Number of Participants With Aneurysm Recanalization
Description
Number of participants with aneurysm recanalization was reported. Recanalization was defined as an increase in aneurysm filling as compared to the previous study-specified angiographic assessment, resulting in a change in (that is, worsening of) the Raymond classification.
Time Frame
Up to 12 months
Title
Number of Participants Retreated With Any Additional Treatment
Description
Retreatment was defined as any additional treatment of the target aneurysm after the index procedure (retreatment includes staged procedures), or an additional procedure (regardless of whether retreatment is by surgery or endovascular treatment) due to recanalization, rupture or bleeding.
Time Frame
Up to 12 months
Title
Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score
Description
Observed scores on the Modified Ranking Scale was presented at baseline (pre-procedure) and follow-up (30 days, 6 and 12 months post-procedure). mRS score: 0 = no symptoms at all; 1 = no significant disability despite symptoms, able to carry out all usual duties and activities; 2 = slight disability, unable to carry out all previous activities but able to look after own affairs without assistant; 3 = moderate disability, requires some help, but able to walk without assistance; 4 = moderate to severe disability, unable to walk without assistance, and unable to attend own bodily needs without assistance; 5 = severe disability, bedridden, incontinent, and requiring constant nursing care and attention; 6 = dead. The number of participants who had an increase in mRS > 2 from baseline not related to stroke or death was also be presented for each follow-up time point.
Time Frame
Post-procedure up to 30-Day, 6-Month Follow-up and 12-Month Follow-up
Title
Number of Participants With NIH Stroke Scale (NIHSS) Worsening
Description
The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The scores range from 0 to 42 with a score of 0 indicates no stroke; 1-4 as minor stroke; 5-15 as moderate stroke; 15-20 as moderate/severe stroke; 21-42 as severe stroke. NIHSS worsening is defined as an increase from baseline of >= 4.
Time Frame
Post-procedure up to 6-Month and 12-Month Follow-up
Title
Number of Participants With Reduced Thrombolysis in Cerebral Infarction (TICI) Flow (New Occurrence of TICI Grade of 0 or 1)
Description
The percentage of target aneurysms in which a new occurrence of unintentional and persistent reduced TICI flow (TICI grade of 0: No perfusion or 1: Partial perfusion) was observed at the target vessel during the index procedure as a result of a mechanical obstruction such as dissection or luminal thrombus was evaluated. TICI evaluates perfusion severity and ranges from Grade 0 (No perfusion) to 3 (Complete perfusion).
Time Frame
Day 1 (Intraoperative)
Title
Number of Participants With Bleeding Complications
Description
The number of participants who experienced a procedure-related hemorrhagic event which required any of the following was evaluated: blood transfusion, surgical intervention, a new hospitalization, or lengthening of hospital stay. The complications of hematoma requiring treatment (that is, hematoma > 5 centimeter [cm] in diameter occurring at the access site) and retroperitoneal bleeding were reported as hemorrhagic events.
Time Frame
12 months
Title
Number of Participants With In-Stent Stenosis Per Independent Core Laboratory During Procedure (Acute), Post-procedure up to 6 Months and 12 Months Follow up
Description
In-stent stenosis is defined as greater than 50% narrowing of the vessel within the ENTERPRISE stent or within 10 mm of either end of the stent.
Time Frame
During procedure (acute), post-procedure up to 6 months and 12 months follow up
Title
Number of Participants With Thrombosis Per Independent Core Laboratory
Description
Thrombosis is defined as in-stent thrombosis.
Time Frame
During procedure (acute), post-procedure up to 6 months and 12 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm
Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment
Subject is willing to comply with specified follow-up evaluation
Exclusion Criteria:
Planned staged procedure
Currently enrolled in another investigational device or drug study
Target aneurysm that has been previously treated
Mycotic, fusiform or dissecting aneurysm
Admission platelet <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >3.0
A serum creatinine level > 2.5 mg/dL within 7 days prior to index procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Frei, MD
Organizational Affiliation
Radiology Imaging Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiology Imaging Associates
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Lyerly Neurosurgery, an Affiliate of Baptist Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606012
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Massachusetts Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Mount Sinai Health System
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
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