ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-08-06

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04852783

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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.	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.

Inclusion Criteria

Exclusion 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.
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.

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.

Contacts and Locations

Principal Investigator

Pascal M Jabbour, MD

PRINCIPAL_INVESTIGATOR

Jefferson University Hospitals

Demetrius Lopes, MD

PRINCIPAL_INVESTIGATOR

Advocate Medical Group - Brain and Spine Institute

Study Locations (Sites)

Swedish Medical Center

Englewood, Colorado, 80113

United States

Baptist Health

Jacksonville, Florida, 32207

United States

University of Chicago

Chicago, Illinois, 60637

United States

Advocate Aurora Health

Park Ridge, Illinois, 60068

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

UMASS Medical Center

Worcester, Massachusetts, 01655

United States

Montefiore Medical Center

Bronx, New York, 10467

United States

University at Buffalo Neurosurgery

Buffalo, New York, 14203

United States

NYU Langone Health

New York, New York, 10016

United States

Stony Brook Medicine

Stony Brook, New York, 11794

United States

Westchester Medical Center

Valhalla, New York, 10595

United States

NC Heart and Vascular Research LLC

Raleigh, North Carolina, 27607

United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

United States

Alejandro Spiotta

Charelston, South Carolina, 29425

United States

Semmes-Murphy Clinic

Memphis, Tennessee, 38120

United States

Medical City Plano

Plano, Texas, 75075

United States

Swedish Neuroscience Institute

Seattle, Washington, 98122

United States

Collaborators and Investigators

Sponsor: Cerus Endovascular, Inc.

Pascal M Jabbour, MD, PRINCIPAL_INVESTIGATOR, Jefferson University Hospitals
Demetrius Lopes, MD, PRINCIPAL_INVESTIGATOR, Advocate Medical Group - Brain and Spine Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-06

Study Completion Date2029-12

Study Record Updates

Study Start Date2021-08-06

Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

Aneurysm, Intracranial