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

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: NCT02532517
Recruitment Status : Terminated (No safety issues; change in innovation strategy)
First Posted : August 25, 2015
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Cerenovus, Part of DePuy Synthes Products, Inc.

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

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enterprise Device: CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System



Primary Outcome Measures :
  1. Rate of Complete Aneurysm Occlusion (RCAO) [ Time Frame: 12 Months ]
  2. Incidence of Major Ipsilateral Stroke and/or Death [ Time Frame: 12 Months ]
  3. Incidence of In-Stent Stenosis [ Time Frame: 12 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532517


Locations
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United States, Colorado
Radiology Imaging Associates
Englewood, Colorado, United States, 80112
United States, Florida
University of Florida
Gainesville, Florida, United States, 32611
Lyerly Neurosurgery, an Affiliate of Baptist Health
Jacksonville, Florida, United States, 32207
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 606012
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01655
United States, New York
University of Buffalo
Buffalo, New York, United States, 14203
Mount Sinai Health System
New York, New York, United States, 10029
United States, Ohio
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
United States, Virginia
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Cerenovus, Part of DePuy Synthes Products, Inc.
Investigators
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Principal Investigator: Donald Frei, MD Radiology Imaging Associates
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Responsible Party: Cerenovus, Part of DePuy Synthes Products, Inc.
ClinicalTrials.gov Identifier: NCT02532517    
Other Study ID Numbers: NV-IDE-1001
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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
Keywords provided by Cerenovus, Part of DePuy Synthes Products, Inc.:
CODMAN ENTERPRISE® Vascular Reconstruction Device
Wide Neck, Intracranial, Saccular Aneurysms
Cerebral Aneurysms
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases