Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device

NCT02532517 | Terminated Results DMC FDA Device

• 1 other identifier: NV-IDE-1001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 11

Brief Summary

The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.

Conditions

Intracranial Aneurysm

Keywords

CODMAN ENTERPRISE® Vascular Reconstruction Device; Wide Neck, Intracranial, Saccular Aneurysms; Cerebral Aneurysms

Outcome Measures

Primary Outcomes (3)

• 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.

  12 Months Post Procedure

• 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.

  At 12 Months Post Procedure

• 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.

  At 12 Months post procedure

Secondary Outcomes (12)

• Number of Participants With Procedure Success Immediately Post-procedure (Acute), 6 and 12 Months

  Immediately post-procedure (acute), 6 and 12 months

• Number of Participants With Complete Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months

  Immediately post-procedure (acute), 6 and 12 months

• Number of Participants With Complete/Partial Aneurysm Occlusion as Per the Raymond Scale Immediately Post-procedure (Acute), 6 and 12 Months

  Immediately post-procedure (acute), 6 and 12 Months

• Number of Participants With 25% to 100% Aneurysm Occlusion Immediately Post-procedure (Acute), 6 and 12 Months

  Immediately post-procedure (acute), 6 and 12 months

• Number of Participants With Aneurysm Recanalization

  Up to 12 months

Study Arms (1)

Enterprise

EXPERIMENTAL

Device: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System

Interventions

CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System DEVICE

Enterprise

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cerenovus, Part of DePuy Synthes Products, Inc.: lead

Study Sites (11)

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Lyerly Neurosurgery, an Affiliate of Baptist Health

Jacksonville, Florida, 32207, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 606012, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Massachusetts Medical Center

Worcester, Massachusetts, 01655, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Mount Sinai Health System

New York, New York, 10029, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Study was terminated due to a low rate of enrollment.

Results Point of Contact

• Title: Christopher Hendricks
• Organization: Cerenovus

CHendric@its.jnj.com

415-656-6565

Study Officials

• Donald Frei, MD

  Radiology Imaging Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: August 25, 2015
• Study Start: September 1, 2015
• Primary Completion: January 8, 2019
• Study Completion: September 21, 2019
• Last Updated: October 23, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (11)