ACTIVE_NOT_RECRUITING

Citadel Embolization Device Study

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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 study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable Coils, in the treatment of wide-neck intracranial aneurysms.

Official Title

The Citadel Embolization Device Study

Quick Facts

Study Start:2019-07-18

Study Completion:2026-11-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04057352

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 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age is ≥18 and ≤80 years 2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment. Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days. 3. Aneurysm morphology is saccular 4. Aneurysm size is between 6-12 mm 5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio \<2 or neck ≥4 mm 6. If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2. 7. Must be willing to comply with protocol required procedures and follow up 8. Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures	1. Target aneurysm has been previously treated 2. Target aneurysm is in any extradural location, including the extradural cavernous segment 3. Has vessel characteristics, tortuosity or morphology or unfavorable aneurysm morphology (e.g., determined from baseline or preprocedure imaging, or which may be evidenced by excessive resistance felt during the procedure) that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device 4. Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging 5. If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt \& Hess Score of ≥ 3 6. Has a history of intracranial vasospasm not responsive to medical therapy 7. Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm 8. Treatment with flow diverting stent implant is anticipated 9. A planned, staged procedure is anticipated 10. Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery 11. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage 12. Has a baseline mRS score ≥2 13. Has a known coagulopathy or is on chronic anticoagulant therapy 14. Is pregnant or intends to become pregnant during the study or is breastfeeding 15. Is concurrently involved in another study that could affect outcomes of IA treatment 16. Has evidence of active cancer, terminal illness, high risk of embolic stroke, unstable atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years 17. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure, and any other contraindications listed in the Investigational DFU 18. Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or other elements used in the manufacturing of the investigational device

Inclusion Criteria

Exclusion Criteria

1. Age is ≥18 and ≤80 years
2. Has a single, unruptured or ruptured target intracranial aneurysm that is suitable for endovascular treatment. Definition: For the purposes of this study, a ruptured intracranial aneurysm is defined as one with CT/MRI/LP evidence of subarachnoid hemorrhage attributed to the index aneurysm within the last 60 days.
3. Aneurysm morphology is saccular
4. Aneurysm size is between 6-12 mm
5. Has a wide-neck, saccular aneurysm, either bifurcation or sidewall, with a dome to neck ratio \<2 or neck ≥4 mm
6. If the target intracranial aneurysm is classified as ruptured, patient must be neurologically stable with a Hunt \& Hess Score of 1 or 2.
7. Must be willing to comply with protocol required procedures and follow up
8. Subject or LAR must be willing to sign and date an IRB approved written informed consent prior to initiation of any screening or study procedures

1. Target aneurysm has been previously treated
2. Target aneurysm is in any extradural location, including the extradural cavernous segment
3. Has vessel characteristics, tortuosity or morphology or unfavorable aneurysm morphology (e.g., determined from baseline or preprocedure imaging, or which may be evidenced by excessive resistance felt during the procedure) that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
4. Has significant intracranial atherosclerotic disease or stenosis determined from baseline or pre-procedure imaging
5. If the target intracranial aneurysm is classified as ruptured, patient is neurologically unstable or has a Hunt \& Hess Score of ≥ 3
6. Has a history of intracranial vasospasm not responsive to medical therapy
7. Has undergone coiling or stenting of a non-target intracranial aneurysm within 30 days prior to study treatment or has a non-target intracranial aneurysm that is expected to be treated within 12 months following the treatment of the target aneurysm
8. Treatment with flow diverting stent implant is anticipated
9. A planned, staged procedure is anticipated
10. Has Moya-Moya disease, arteriovenous malformation(s), arteriovenous fistula(e), intracranial tumor(s), intracranial hematoma(s), any other intracranial vascular malformation, or any previous major intracranial surgery
11. Has had a recent (within 90 days) ischemic stroke, TIA, or intracranial hemorrhage
12. Has a baseline mRS score ≥2
13. Has a known coagulopathy or is on chronic anticoagulant therapy
14. Is pregnant or intends to become pregnant during the study or is breastfeeding
15. Is concurrently involved in another study that could affect outcomes of IA treatment
16. Has evidence of active cancer, terminal illness, high risk of embolic stroke, unstable atrial fibrillation, significant co-morbidities, major surgery ≤ 30 days pre-procedure, psychiatric disorders, substance abuse, or a life expectancy of less than 5 years
17. Has a contraindication to angiography, radiographic contrast agents, or any medications that are typically used during the procedure, and any other contraindications listed in the Investigational DFU
18. Has a confirmed allergy to platinum, tungsten, nickel (e.g. nitinol), or other elements used in the manufacturing of the investigational device

Contacts and Locations

Principal Investigator

Ansaar Rai, MD

PRINCIPAL_INVESTIGATOR

West Virginia University

Study Locations (Sites)

Carondelet St. Joseph Hospital

Tucson, Arizona, 85710

United States

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

California Pacific Medical Center

San Francisco, California, 94114

United States

UCSF Medical Center

San Francisco, California, 94143

United States

John Muir Health

Walnut Creek, California, 94598

United States

RIA Neurovascular

Englewood, Colorado, 80113

United States

University of Florida

Gainesville, Florida, 32608

United States

Baptist Health

Jacksonville, Florida, 32207

United States

University of Miami/Jackson Memorial

Miami, Florida, 33136

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Northwestern University

Chicago, Illinois, 60611

United States

Indiana Methodist

Indianapolis, Indiana, 46202

United States

Kansas University Medical Center

Kansas City, Kansas, 66160

United States

Baptist Health

Lexington, Kentucky, 40503

United States

University of Kentucky

Lexington, Kentucky, 40506

United States

UMass Memorial Health

Worcester, Massachusetts, 01605

United States

McLaren Health Center

Flint, Michigan, 48532

United States

Spectrum Health

Grand Rapids, Michigan, 49503

United States

Washington University

St Louis, Missouri, 63110

United States

Weill Cornell

New York, New York, 10021

United States

Montefiore Medical Center

New York, New York, 10467

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Oregon Health & Sciences University (OHSU)

Portland, Oregon, 97239

United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

University of Washington

Seattle, Washington, 98104

United States

West Virginia University Hospital

Morgantown, West Virginia, 26506

United States

Collaborators and Investigators

Sponsor: Stryker Neurovascular

Ansaar Rai, MD, PRINCIPAL_INVESTIGATOR, West Virginia University

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 Date2019-07-18

Study Completion Date2026-11-15

Study Record Updates

Study Start Date2019-07-18

Study Completion Date2026-11-15

Terms related to this study

Additional Relevant MeSH Terms

Unruptured Wide-neck Aneurysms