US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

Aneurysm, Intracranial Clinical Trial

— NECC  

Official title:

US IDE Study of the Contour NEurovasCular System™ for IntraCranial Aneurysm Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852783
• Other study ID #: DNX102-01
• Status: Recruiting
• Phase: Phase 4
• Start date: August 6, 2021
• Est. completion date: July 2029

Study information

• Verified date: April 2024
• Source: Cerus Endovascular, Ltd
• Contact: Carin Lindquist
• Phone: (510) 946-2787
• Email: Carin.Lindquist[@]stryker.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 2029
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Intracranial
• Intracranial Aneurysm

Intervention

Device:
• Contour Neurovascular System
Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University at Buffalo Neurosurgery	Buffalo	New York
United States	Alejandro Spiotta	Charleston	South Carolina
United States	University of Chicago	Chicago	Illinois
United States	Swedish Medical Center	Englewood	Colorado
United States	Baptist Health	Jacksonville	Florida
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Semmes-Murphy Clinic	Memphis	Tennessee
United States	NYU Langone Health	New York	New York
United States	Advocate Aurora Health	Park Ridge	Illinois
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	Medical City Plano	Plano	Texas
United States	NC Heart and Vascular Research LLC	Raleigh	North Carolina
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Stony Brook Medicine	Stony Brook	New York
United States	Westchester Medical Center	Valhalla	New York
United States	UMASS Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Cerus Endovascular, Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint: 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.	30 days
Primary	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.	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.	1 year
Secondary	Key Secondary Effectiveness Endpoint	The trial's secondary endpoint is the proportion of subjects with angiographic aneurysmal recurrence defined as aneurysm growth or recanalization at one (1) year after treatment.	1 year
Secondary	Key Secondary Safety Endpoint	Proportion of subjects with death of any non-accidental cause or any major stroke (an ischemic or hemorrhagic stroke resulting in an increase of 4 points or more on the NIHSS as of day 7 post onset) within the first 30-days after treatment or major ipsilateral stroke or death due to neurologic cause from day 31 to 365 after treatment.; A major stroke is "a stroke, which increased the NIHSS by = 4 at the time of assessment and which remained present after 7 days"	1 year