Contour Neurovascular System™ ContiNued Access Investigational Device EXempTion (IDE) Trial (NEXT Trial)
NEXT
1 other identifier
interventional
250
1 country
9
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2024
CompletedFirst Posted
Study publicly available on registry
November 18, 2024
CompletedStudy Start
First participant enrolled
June 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
March 31, 2026
March 1, 2026
3.3 years
November 8, 2024
March 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Incidence of Serious Adverse Events (SAE) associated with the procedure or device
From enrollment to 2 years
Proportions of aneurysm occlusion ratings
From enrollment to 2 years
Incidence of stroke resulting in a disabling deficit
From enrollment to 2 years
Incidence of serious neurological events
From enrollment to 2 years
Proportions of device movement ratings
From enrollment to 2 years
Study Arms (1)
Treatment Attempt with the Contour Neurovascular System
EXPERIMENTALSubjects for which the index procedure (implant of the Contour Neurovascular System) was attempted.
Interventions
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
Eligibility Criteria
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 after 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\^6
- 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.\^6
- Patient must be neurologically stable with Hunt \& Hess Score of I, II or III.
- +1 more criteria
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) 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 computed tomography (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).
- Subarachnoid hemorrhage (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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Advocate Aurora Health
Park Ridge, Illinois, 60068, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
University at Buffalo Neurosurgery
Buffalo, New York, 14203, United States
Stony Brook University
Stony Brook, New York, 11794, United States
NC Heart and Vascular Research LLC
Raleigh, North Carolina, 27607, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2024
First Posted
November 18, 2024
Study Start
June 10, 2025
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
January 1, 2030
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share