Cross-Seal (Large Bore Closure) IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-Seal Suture-Mediated Vascular Closure Device System
Sponsor: |
Terumo Medical Corporation |
Enrolling: |
Male and Female Patients |
Study Length: |
60 Days |
Clinic Visits: |
5 |
IRB Number: |
AAAS4111 |
U.S. Govt. ID: |
NCT03756558 |
Contact: |
Claudia Musat, Research Manager: (212) 342-4102 / cm2065@cumc.columbia.edu |
Are you scheduled for an interventional vascular procedure, such as a Trans-catheter Aortic Valve Replacement (TAVR), Endovascular Aneurysm Repair (EVAR), Thoracic Endovascular Aortic Repair (TEVAR), or Balloon Aortic Valvuloplasty (BAV)? If yes, you may be eligible for this trial. This research trial studies the safety and efficacy of an Investigational Device (IDE) called the Cross-Seal Suture-Mediated Vascular Closure Device System. This device has not yet been approved by the FDA for use on the market.The device delivers percutaneous sutures (administers stitches through the skin) for the closure of large holes created in the common femoral artery access site during your endovascular procedure. The objective of the device is to safely and effectively help achieve hemostasis (the stopping of bleeding) of the artery in your thigh that was punctured for your surgery.
This study is closed
Investigator
Virendra Patel, MD
Are you at least 18 years old? |
Yes |
No |
Are you scheduled for an elective or planned (e.g. not emergency) procedure involving access through the femoral artery? |
Yes |
No |