Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure … (NCT03756558) | Clinical Trial Compass
CompletedNot Applicable
Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
United States147 participantsStarted 2019-08-09
Plain-language summary
This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 18 years old
✓. Subject is scheduled for elective or planned (i.e., not emergent or urgent) percutaneous transcatheter interventional procedures involving access through the femoral artery using 8-18 French introducer sheaths
✓. Subject is able to undergo emergent vascular surgery if a complication related to the vascular closure necessitates such surgery
✓. Subject is willing and able to complete follow-up requirements
✓. Subject, or authorized representative signs a written Informed Consent form prior participating in the study
Exclusion criteria
✕. Prior intra-aortic balloon pump at access site
✕. Subjects with severe inflow disease (iliac artery diameter stenosis \> 50%) and/or severe peripheral arterial disease (Rutherford Classification 5 or 6), as confirmed with prior standard of care Computed Tomography Imaging, duplex ultrasound, and/or intra-procedural fluoroscopy
✕. Common femoral artery lumen diameter is \< 5 mm
✕. In opinion of the investigator, significant scarring of the target access site which would preclude use of the device in accordance with the IFU
✕. Prior target artery closure with any closure device \< 90 days, or closure with manual compression ≤ 30 days prior to index procedure
✕. Prior vascular surgery, vascular graft, or stent in region of access site