Cross-SealTM IDE Trial: Prospective, Multi-Center, Single Arm Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Closure
- Sponsor
- Terumo Medical Corporation
- Enrollment
- 147
- Locations
- 20
- Primary Endpoint
- Freedom From Major Complications
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Detailed Description
The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
Investigators
Eligibility Criteria
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
- •General 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
- •Subjects receiving glycoprotein IIb/IIIa inhibitors before, during, or after the catheterization procedure
- •Subjects with significant anemia
- •Subject with known bleeding disorder including thrombocytopenia (platelet count \< 100,000), thrombasthenia, hemophilia or Von Willebrand's disease
Outcomes
Primary Outcomes
Freedom From Major Complications
Time Frame: 30 days post procedure
Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection
Mean Time To Hemostasis (TTH)
Time Frame: Index Procedure
The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
Secondary Outcomes
- Freedom From Minor Complications(30 days post procedure)
- Number of Participants With Device Related Complications Within 30 Days Post-procedure(30 days post procedure)
- Incidence of Adverse Events(60 days post procedure)
- Incidence of Technical Success(Immediately Post-procedure (procedure approximately 8 hours))
- Incidence of Closure Success(Within 48 hours of the index procedure or hospital discharge, whichever occurs first)
- Incidence of Treatment Success(30 days post procedure)
- Incidence of Surgical or Endovascular Intervention Post Closure(30 days post procedure)
- Incidence of Manual Compression(Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours)
- Time-to-Ambulation:(From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours)
- Incidence of Device Failure(30 days post procedure)
- Incidence of Procedure Related Complications(30 days post procedure)