Cross-Seal IDE Trial: Prospective, Multicenter, Single Arm Study of the Cross-Seal Suture Mediated Vascular Closure Device System
Cross-Seal: Study of the Cross-Seal Suture Mediated Vascular Closure Device System
Sponsor: Terumo Interventional Systems
Enrolling: Male and Female Patients
Study Length: 18 Months
Clinic Visits: 2
IRB Number: AAAS6453
U.S. Govt. ID: NCT03756558
Contact: Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu
Additional Study Information: Are you scheduled for an interventional vascular procedure (e.g. BAV, TAVR/TAVI, EVAR or TEVAR) inorder to replace a damaged or failing valve? This research style 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 bores created in the common femoral artery access site during your endovascular aneurysm repair surgery. 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. Patients who agree to join this study must sign and date an informed consent form, and will be asked to undergo the following tests and procedures, unless already performed as per standard of care prior to surgery: Medical history assessment against the eligibility criteria for this research trial; Blood test to screen for Complete Blood Count (CBC), Platelet Count, Serum Creatinine, Hemoglobin (HGB), Blood Urea Nitrogen (BUN), and Hematocrit (HCT) 2 weeks prior to procedure; If you are a person of child-bearing potential, a urine or serum test for non-pregnant status within 7 days prior to procedure; A CT (Computed Tomography) Scan with contrast agent collected within 6 months prior to the procedure; After the study procedure, the condition of study subjects and devices will be monitored prior to hospital discharge, and then at 30 Days and 60 Days post-discharge. Subjects will be asked to return to the hospital at Day 30 and Day 60 after discharge so that the study team can monitor their medical condition and device condition via Targeted Physical Exams (including a groin exam), Femoral Duplex Ultrasound (DUS) imaging, medications to prevent blood clotting, and assessment of any adverse events.
This study is closed
Investigator
Tamim Nazif, MD
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Are you greater than or equal to 18 years? Yes No
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For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366