US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
NCT ID: NCT04852783
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE4
250 participants
INTERVENTIONAL
2021-08-06
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Attempted to Treat
Attempted to treat (ATT) with the investigational device
Contour Neurovascular System
Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Contour Neurovascular System
Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cerus Endovascular, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pascal M Jabbour, MD
Role: PRINCIPAL_INVESTIGATOR
Jefferson University Hospitals
Demetrius Lopes, MD
Role: PRINCIPAL_INVESTIGATOR
Advocate Medical Group - Brain and Spine Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Swedish Medical Center
Englewood, Colorado, United States
Baptist Health
Jacksonville, Florida, United States
University of Chicago
Chicago, Illinois, United States
Advocate Aurora Health
Park Ridge, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
UMASS Medical Center
Worcester, Massachusetts, United States
University at Buffalo Neurosurgery
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
Stony Brook Medicine
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Westchester Medical Center
Valhalla, New York, United States
NC Heart and Vascular Research LLC
Raleigh, North Carolina, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Alejandro Spiotta
Charelston, South Carolina, United States
Semmes-Murphy Clinic
Memphis, Tennessee, United States
Medical City Plano
Plano, Texas, United States
Swedish Neuroscience Institute
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DNX102-01
Identifier Type: -
Identifier Source: org_study_id