Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial) (NEXT)

Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial

The goal of this clinical trial is to collect additional data to demonstrate if the Contour Neurovascular System (CNS) is a safe and effective treatment of wide-necked, saccular, intracranial aneurysms.

Participants will:

Undergo treatment with the Contour Neurovascular System Complete follow-up visits at 1month, 12months, and 24 months, following their procedure Report any adverse events to their study team

Study Overview

• Status: Recruiting
• Conditions: Cerebral Aneurysms
• Intervention / Treatment: Device: Contour Neurovascular System Treatment Attempt

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanessa Sarge; Phone Number: 510-329-2048; Email: vanessa.sarge@stryker.com
• Study Contact Backup: Name: Amelia Saliba; Phone Number: 408-582-4552; Email: amelia.saliba@stryker.com

Study Locations

• United States
  • Illinois
    • Park Ridge, Illinois, United States, 60068
      • Recruiting
      • Advocate Aurora Health
      • Principal Investigator: Demetrius Lopes, MD
      • Contact: Gina Littlejohn, 847-723-2099; Email: Gina.Littlejohn@aah.org
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Principal Investigator: Koji Ebersole, MD
      • Contact: Jason Gorup; Phone Number: 913-588-6122; Email: jgorup@kumc.edu
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University at Buffalo Neurosurgery
      • Contact: Ellen Carl; Phone Number: 716-472-9560; Email: ecarl@ubns.com
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University
      • Contact: Marlene Baumeister; Phone Number: 631-444-1213
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • NC Heart and Vascular Research LLC
      • Contact: Jennifer Vanduine; Phone Number: 919-784-3100; Email: jennifer.vanduine@unchealth.unc.edu
      • Principal Investigator: Tibor Beckse, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Leah Coghlan; Phone Number: 215-341-5864; Email: leah.coghlan@pennmedicine.upenn.edu
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Thomas Jefferson University
      • Principal Investigator: Pascal Jabbour, MD
      • Contact: Danna Smith; Phone Number: 215-955-2173; Email: danna.smith@jefferson.edu
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Alejandro Spiotta, MD
      • Contact: Melza Goffinet; Phone Number: 843-792-1679; Email: vanroije@musc.edu
  • Washington
    • Seattle, Washington, United States, 98122
      • Recruiting
      • Swedish Neuroscience Institute
      • Contact: Laura Johnson; Phone Number: 206- 320-2800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 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 after 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^6

   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.^6
9. Patient must be neurologically stable with Hunt & Hess Score of I, II or III.

(^6: 6 https://www.ahajournals.org/doi/full/10.1161/STR.0000000000000070)

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) 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 computed tomography (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. Subarachnoid hemorrhage (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: Treatment Attempt with the Contour Neurovascular System; Subjects for which the index procedure (implant of the Contour Neurovascular System) was attempted.	Device: Contour Neurovascular System Treatment Attempt; The subject is brought into the procedure room, an angiogram on the day of the procedure indicates that the subject is anatomically eligible for the trial and any part of the investigational device comes in contact with the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 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. Stroke is defined per the World Health Organization as: rapidly developing clinical signs of focal or global disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin, including ischemic stroke and/or hemorrhagic stroke.	From enrollment to 1 year
Proportion of complete occlusion of the aneurysm with Contour, without retreatment, recurrent subarachnoid hemorrhage, or significant parent artery stenosis at one (1) year after treatment.	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. The Raymond-Roy Scale grades aneurysms on a scale of one (1) to three (3) with a lower score correlating with a more favorable outcome. The Raymond-Roy Scale will be graded in accordance with the following definitions: Class 1 (Complete obliteration of the aneurysm), Class 2 (Persistence of any portion of the original defect of the arterial wall as seen on any single projection but without opacification of the aneurysmal sac), or Class 3 (Any opacification of the aneurysmal sac).	From enrollment to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Events (SAE) associated with the procedure or device	Serious Adverse Events (SAE) associated with the procedure or device, both individually and in aggregate	From enrollment to 2 years
Proportions of aneurysm occlusion ratings	·Detailed assessment of aneurysm occlusion from post procedure to one (1) year (and also at two (2) years for any aneurysm not completely occluded at 1 year) provided by the core lab review of the angiogram, including the following: Complete occlusion (Raymond Roy Scale of 1); Adequate Occlusion (Raymond Roy Scale of 1 or 2); Raymond Roy scale The Raymond-Roy Scale grades aneurysms on a scale of one (1) to three (3) with a lower score correlating with a more favorable outcome. The Raymond-Roy Scale will be graded in accordance with the following definitions: Class 1 (Complete obliteration of the aneurysm), Class 2 (Persistence of any portion of the original defect of the arterial wall as seen on any single projection but without opacification of the aneurysmal sac), or Class 3 (Any opacification of the aneurysmal sac).	From enrollment to 2 years
Incidence of stroke resulting in a disabling deficit	Assessment of incidence of stroke resulting in a disabling deficit, defined operationally as a deficit that, if unchanged, would prevent the patient from performing basic activities of daily living (i.e., bathing, ambulating, toileting, hygiene, and eating) or returning to work (mRS ≥ 3).	From enrollment to 2 years
Incidence of serious neurological events	All serious neurological adverse events	From enrollment to 2 years
Proportions of device movement ratings	·Detailed assessment of aneurysm occlusion from post procedure to one (1) year (and also at two (2) years for any aneurysm not completely occluded at 1 year) provided by the core lab review of the angiogram, including the following: o Device position (remains in place, migration into the parent artery or movement towards the aneurysm dome)	From enrollment to 2 years

Collaborators and Investigators

• Sponsor: Cerus Endovascular, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 18, 2024

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

• Keywords: aneurysm; wide-neck; saccular; bifurcated
• 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: DNX140-01

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