US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

Who is this study for? Patients with intracranial aneurysms
What treatments are being studied? Contour neurovascular system
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this trial is to gather data on the safety and effectiveness of the Contour /Contour 021 System in the treatment of wide-necked bifurcated saccular, intracranial aneurysms for submission to FDA in support of a premarket approval application for the device.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Patient is 18-75 years of age at the time of screening.

• Patient has a single ruptured or unruptured IA requiring treatment. If the patient has an additional IA requiring treatment, the additional IA must not require treatment within 60 days of the index procedure.

• The target IA must have the following characteristics:

• Saccular morphology

• Located at a bifurcation in the anterior or posterior circulation

• Aneurysm neck diameter between 2 and 10 mm and aneurysm equatorial diameter between 2 and 10.5 mm

• Wide-necked, defined as neck size ≥ 4 mm or a dome/neck ratio < 2

• Patient may be treated with Contour without the use of additional implanted devices.

• Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.

• Patient or legally authorized representative has signed and dated an institutional review board (IRB)/Ethics Committee (EC)-approved written informed consent prior to initiation of any study procedures.

• FOR PATIENTS WITH UNRUPTURED ANEURYSM

• Patient meets the criteria outlined in the Guidelines for the Management of Patients With Unruptured Intracranial Aneurysms as published by the AHA/ASA FOR PATIENTS WITH RUPTURED ANEURYSM

• Patient meets the criteria outlined in the Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association as published by the AHA/ASA.

• Patient must be neurologically stable with Hunt & Hess Score of I, II or III.

Locations
United States
Colorado
Swedish Medical Center
Recruiting
Englewood
Florida
Baptist Health
Recruiting
Jacksonville
Illinois
Advocate Aurora Health
Recruiting
Park Ridge
Kansas
University of Kansas Medical Center
Recruiting
Kansas City
Massachusetts
Massachusetts General Hospital
Not yet recruiting
Boston
UMASS Medical Center
Recruiting
Worcester
North Carolina
NC Heart and Vascular Research LLC
Recruiting
Raleigh
New York
Montefiore Medical Center
Recruiting
Bronx
University at Buffalo Neurosurgery
Recruiting
Buffalo
NYU Langone Health
Recruiting
New York
Stony Brook Medicine
Recruiting
Stony Brook
Westchester Medical Center
Recruiting
Valhalla
Pennsylvania
The Hospital of the University of Pennsylvania
Recruiting
Philadelphia
Thomas Jefferson University
Recruiting
Philadelphia
University of Pittsburgh Medical Center
Recruiting
Pittsburgh
Tennessee
Semmes-Murphy Clinic
Recruiting
Memphis
Texas
Medical City Plano
Recruiting
Plano
Washington
Swedish Neuroscience Institute
Recruiting
Seattle
Contact Information
Primary
Lori E Adels, PhD
lori.adels@cerusendo.com
510-651-4000
Time Frame
Start Date: August 6, 2021
Estimated Completion Date: September 2027
Participants
Target number of participants: 220
Sponsors
Leads: Cerus Endovascular, Ltd

This content was sourced from clinicaltrials.gov