Clinical trial NCT02532517: 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
Overall status: TERMINATED
Phase: NA
Conditions: Intracranial Aneurysm
Keywords: CODMAN ENTERPRISE® Vascular Reconstruction Device
Wide Neck, Intracranial, Saccular Aneurysms
Cerebral Aneurysms
Lead sponsor: Cerenovus, Part of DePuy Synthes Products, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-25
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Complete Aneurysm Occlusion (RCAO) Without Retreatment at 12-Month Post Procedure
timeFrame: 12 Months Post Procedure
measure: Percentage of Participants With Major Ipsilateral Stroke and/or Death Due to Ipsilateral Stroke at 12 Months Post Procedure
timeFrame: At 12 Months Post Procedure
measure: Percentage of Participant With In-Stent Stenosis at 12 Months Post Procedure Per Independent Core Laboratory
timeFrame: At 12 Months post procedure
Secondary outcomes:
measure: Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months
timeFrame: Immediately post-procedure (acute), 6 and 12 months
measure: Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
timeFrame: Immediately post-procedure (acute), 6 and 12 months
measure: Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months
timeFrame: Immediately post-procedure (acute), 6 and 12 Months
measure: Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months
timeFrame: Immediately post-procedure (acute), 6 and 12 months
measure: Number of Participants With Aneurysm Recanalization
timeFrame: Up to 12 months
measure: Number of Participants Retreated With Any Additional Treatment
timeFrame: Up to 12 months
measure: Number of Participants With New Neurological Deficits as Per the Modified Rankin Scale (mRS) Score
timeFrame: Post-procedure up to 30-Day, 6-Month Follow-up and 12-Month Follow-up
measure: Number of Participants With NIH Stroke Scale (NIHSS) Worsening
timeFrame: Post-procedure up to 6-Month and 12-Month Follow-up
measure: Number of Participants With Reduced Thrombolysis in Cerebral Infarction (TICI) Flow (New Occurrence of TICI Grade of 0 or 1)
timeFrame: Day 1 (Intraoperative)
measure: Number of Participants With Bleeding Complications
timeFrame: 12 months
measure: 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
timeFrame: During procedure (acute), post-procedure up to 6 months and 12 months follow up
measure: Number of Participants With Thrombosis Per Independent Core Laboratory
timeFrame: During procedure (acute), post-procedure up to 6 months and 12 months follow up
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Lyerly Neurosurgery, an Affiliate of Baptist Health
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Medical Center
state: Massachusetts
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Radiology Imaging Associates
name: Donald Frei, MD
role: PRINCIPAL_INVESTIGATOR
References: