A Multi-Center, Prospective, Randomized, Controlled, Trial to Evaluate the Safety and Efficacy of the Cardiva VASCADE VCS vs. Manual Compression for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgical Wound
- Sponsor
- Cardiva Medical, Inc.
- Enrollment
- 420
- Locations
- 21
- Primary Endpoint
- Time to Hemostasis (TTH)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
Detailed Description
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing femoral arterial access sites and providing reduced times to hemostasis and ambulation compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control ratio.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath
- •Pre-Operative
Exclusion Criteria
- •Advanced refusal of blood transfusion, if necessary;
- •Active systemic or a cutaneous infection or inflammation;
- •Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids;
- •Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours);
- •Severe co-existing morbidities having a life expectancy of less than 30 days;
- •Currently involved in any other investigational clinical trial;
- •Ipsilateral femoral arteriotomy within the previous 30 days;
- •Planned endovascular procedure within the next 30 days;
- •Previous ipsilateral femoral artery closure using a permanent implant-based closure device;
- •Previous vascular grafts or surgery at the target vessel access site;
Outcomes
Primary Outcomes
Time to Hemostasis (TTH)
Time Frame: Up to 1 hour
Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Rate of Combined Access Site-related Major Complications
Time Frame: 30 days +/- 7 days
Primary safety endpoint * Access site-related bleeding requiring transfusion; * Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft); * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; * Permanent access site-related nerve injury. (\> 30 days)
Secondary Outcomes
- Time to Ambulation (TTA)(Up to 1 day)
- Device Success(Up to 1 day)
- Rate of Combined Minor Access Site Complications(30 days +/- 7 days)
- Time to Discharge Eligibility (TTDE)(Up to 2 days)
- Time to Hospital Discharge (TTHD)(Up to 2 days)
- Procedure Success(30 days +/- 7 days)