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

A vizsgálat adatai

Ki végzi

Cerus Endovascular, Inc.

Azonosító

NCT06693011

A regiszteradat frissítve

2026. március 31.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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

Kizáró feltételek: 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; Anticoagulation medications (e.g., warfarin) that cannot be discontinued; 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; Modified Rankin Scale (mRS) score ≥ 2 prior to presentation or rupture (as applicable); Subject is enrolled in another device or drug study in which participation could confound study results; Subject has a known, untreatable hypersensitivity to contrast dye, iodine, or any component of the treatment device; Vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device; Any circulatory, neurovascular, cardiovascular, or neurologic conditions that can result in unstable neurological symptoms (e.g., multiple sclerosis, established seizure disorder); 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; Life expectancy of less than 2 years due to an illness or condition other than the index intracranial aneurysm; Contraindication to anticoagulants or anti-platelet medications; Acute / chronic renal failure (unless on dialysis) or creatinine > 2.00 mg/dl or > 182 μmol/L; Stenosis of the target IA's parent vessel is >50%; Clinical, angiographic or computed tomography (CT) evidence of vasospasm, vasculitis, an intracranial tumor (except small meningioma) or any other intracranial vascular malformations on presentation; Pregnant, breastfeeding or planning pregnancy in the next 2 years.

ClinicalTrials.gov NCT06693011