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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aneurysm, Intracranial
• Intervention / Treatment: Device: Contour Neurovascular System

Detailed Description

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. This trial is a prospective, multicenter single-arm study. Up to 220 subjects will be enrolled at up to 20 participating investigational sites.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Park Ridge, Illinois, United States, 60068
      • Advocate Aurora Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Worcester, Massachusetts, United States, 01655
      • UMASS Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • University at Buffalo Neurosurgery
    • New York, New York, United States, 10016
      • NYU Langone Health
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medicine
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Valhalla, New York, United States, 10595
      • Westchester Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart and Vascular Research LLC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
    • Philadelphia, Pennsylvania, United States, 19104
      • The Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charelston, South Carolina, United States, 29425
      • Alejandro Spiotta
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Semmes-Murphy Clinic
  • Texas
    • Plano, Texas, United States, 75075
      • Medical City Plano
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Neuroscience Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient is 18-75 years of age at the time of screening.
2. 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.

3. 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
4. Patient may be treated with Contour without the use of additional implanted devices.
5. Patient is able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule.

6. 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

7. 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
8. 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.
9. Patient must be neurologically stable with Hunt & Hess Score of I, II or III.

Exclusion Criteria:

1. Anatomy or physiology considered unsuitable for endovascular treatment with the Contour device by the implanting physician and/or the Patient Selection Committee
2. Target IA contains other devices/implants (e.g., coils) that could interfere with the correct placement of the Contour device
3. Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device.
4. Contraindication to anticoagulants or anti-platelet medications
5. Stenosis of the target IA's parent vessel is >50%
6. Anticoagulation medications (e.g., warfarin) that cannot be discontinued
7. Acute / chronic renal failure (unless on dialysis) and/or creatinine > 2.00 mg/dl or > 182 μmol/L
8. Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
9. Clinical, angiographic or CT evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation.
10. 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.
11. Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder).
12. modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable).
13. SAH from a non-index aneurysm or any other intracranial hemorrhage within 90 days.
14. 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.
15. Pregnant, breastfeeding or planning pregnancy in the next 2 years
16. Subject is enrolled in another device or drug study in which participation could confound study results.
17. Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attempted to Treat; Attempted to treat (ATT) with the investigational device	Device: Contour Neurovascular System; Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Key Secondary Effectiveness Endpoint	The trial's secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.	1 year
Key Secondary Safety Endpoint	Proportion of subjects with death of any non-accidental cause or any major stroke (an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the NIHSS as of day 7 post onset) within the first 30-days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 after treatment. A major stroke is "a stroke, which increased the NIHSS by ≥ 4 at the time of assessment and which remained present after 7 days"	1 year

Collaborators and Investigators

• Sponsor: Cerus Endovascular, Inc.
• Investigators: Principal Investigator: Pascal M Jabbour, MD, Jefferson University Hospitals; Principal Investigator: Demetrius Lopes, MD, Advocate Medical Group - Brain and Spine Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2021
• Primary Completion (Actual): February 20, 2026
• Study Completion (Estimated): February 1, 2030

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: DNX102-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No