Clinical trial NCT04852783: US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
Official title: US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Aneurysm, Intracranial
Lead sponsor: Cerus Endovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This trial is a prospective, multicenter single-arm study.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Endpoint: Death or stroke within 30 days of treatment or ipsilateral stroke or neurological death between 30 days and 1 year.
timeFrame: 30 days
measure: 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.
timeFrame: 1 year
Secondary outcomes:
measure: Key Secondary Effectiveness Endpoint
timeFrame: 1 year
measure: Key Secondary Safety Endpoint
timeFrame: 1 year
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Health
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Aurora Health
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University at Buffalo Neurosurgery
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Raleigh
country: United States
facility: NC Heart and Vascular Research LLC
state: North Carolina
city: Philadelphia
country: United States
facility: The Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charelston
country: United States
facility: Alejandro Spiotta
state: South Carolina
city: Memphis
country: United States
facility: Semmes-Murphy Clinic
state: Tennessee
city: Plano
country: United States
facility: Medical City Plano
state: Texas
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
Study officials:
affiliation: Jefferson University Hospitals
name: Pascal M Jabbour, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advocate Medical Group - Brain and Spine Institute
name: Demetrius Lopes, MD
role: PRINCIPAL_INVESTIGATOR
References: