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

NCT04852783 | Active Not Recruiting Phase 4 DMC FDA Device

• 1 other identifier: DNX102-01
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Aneurysm, Intracranial

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.

  Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.

  30 days

• Primary Effectiveness Endpoint: Complete occlusion of the aneurysm with Contour without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment as assessed by the angiographic core laboratory.

  Complete occlusion of the aneurysm with Contour as defined by complete aneurysm occlusion (Raymond Roy Scale , of 1) without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis (\> 50% stenosis) at one (1) year after treatment as assessed by the angiographic core laboratory.

  1 year

Secondary Outcomes (2)

• Key Secondary Effectiveness Endpoint

  1 year

• Key Secondary Safety Endpoint

  1 year

Study Arms (1)

Attempted to Treat

EXPERIMENTAL

Attempted to treat (ATT) with the investigational device

Device: Contour Neurovascular System

Interventions

Contour Neurovascular System DEVICE

Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.

Attempted to Treat

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
• Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
• Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
• Contraindication to anticoagulants or anti-platelet medications
• Stenosis of the target IA's parent vessel is \>50%
• Anticoagulation medications (e.g., warfarin) that cannot be discontinued
• Acute / chronic renal failure (unless on dialysis) and/or creatinine \> 2.00 mg/dl or \> 182 μmol/L
• Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
• Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
• Conditions placing them at high risk for ischemic stroke or had exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 60-days.
• Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder).
• modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable).
• SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days.
• Physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.
• Pregnant, breastfeeding or planning pregnancy in the next 2 years

Sponsors & Collaborators

• Cerus Endovascular, Inc.: lead

Study Sites (20)

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Advocate Aurora Health

Park Ridge, Illinois, 60068, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

UMASS Medical Center

Worcester, Massachusetts, 01655, United States

Location

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Westchester Medical Center

Valhalla, New York, 10595, United States

Location

NC Heart and Vascular Research LLC

Raleigh, North Carolina, 27607, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Alejandro Spiotta

Charelston, South Carolina, 29425, United States

Location

Semmes-Murphy Clinic

Memphis, Tennessee, 38120, United States

Location

Medical City Plano

Plano, Texas, 75075, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

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

Study Officials

• Pascal M Jabbour, MD

  Jefferson University Hospitals

  PRINCIPAL INVESTIGATOR

• Demetrius Lopes, MD

  Advocate Medical Group - Brain and Spine Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This trial is a prospective, multicenter single-arm study.

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: August 6, 2021
• Primary Completion: February 20, 2026
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)