AMBULATE: Multi-center, RCT for Safety & Efficacy of Cardiva Mid-Bore Venous VCS v. Manual Compression to Close Femoral Venotomies After Catheter-based Interventions Via 6-12F ID Sheaths With Single or Multiple Access Sites Per Limb
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Surgical Wound
- Sponsor
- Cardiva Medical, Inc.
- Enrollment
- 204
- Locations
- 13
- Primary Endpoint
- Time to Ambulation (TTA)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of the trial is to demonstrate the safety and effectiveness of the Cardiva Mid-Bore Venous Vascular Closure System (VVCS) in sealing femoral venous access sites and providing reduced times to ambulation (TTA) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths.
Detailed Description
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 Fr introducer sheaths. Only patients with multiple access sites will be enrolled in order to support the desired indication. Randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 Fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg
- •Anticipated prolonged bedrest (5 hours or more) and / or overnight stay
Exclusion Criteria
- •Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- •Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
- •Know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count \< 100,000 cells/mm3
- •Severe co-existing morbidities with life expectancy less than 12 months
- •Femoral arteriotomy or femoral venotomy in \< 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
- •Planned femoral venous or arterial access within next 30 days
- •History of DVT, pulmonary embolism or thrombophlebitis
- •Significant anemia or renal insufficiency
- •BMI \> 45 kg/m2 or \< 20 kg/m2
- •Unable to routinely walk at least 20 ft. without assistance
Outcomes
Primary Outcomes
Time to Ambulation (TTA)
Time Frame: Post-procedure, usually within 6 hours
Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject stands and walks 20 feet without evidence of venous re-bleeding from the femoral access site.
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event
Time Frame: 30 +/- 7 days post-procedure
Rate of combined major venous access site closure-related complications. The method used to determine what would be considered "major" venous access site closure-related complications are those complications which were attributed directly to the closure method used for the access site at the end of the procedure.
Secondary Outcomes
- Time to Discharge (TTD)(Prior to hospital discharge, usually within 24 hours)
- Number of Participants With Procedure Success(30 +/- 7 days post-procedure)
- Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event(30 +/- 7 days post-procedure)
- Total Post-Procedure Time (TPPT)(Post-procedure, usually within 6 hours)
- Time to Discharge Eligibility (TTDE)(Prior to hospital discharge, usually within 24 hours)
- Time to Hemostasis (TTH)(Post-procedure, usually within 3 hours)
- Time to Closure Eligibility (TTCE)(Post-procedure, usually within 6 hours)
- Number of Access Sites With Device Success(Procedural, usually within 15 minutes of enrollment)