AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Surgical Wound

Intervention / Treatment
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* Device: Cardiva Mid-Bore VVCS
* Other: Manual compression


Participation Criteria
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Eligibility Criteria
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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 LMWH within 8 hours before or after procedure Access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; < 6 Fr or > 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be < 2.5 cm deep

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects randomized in 1:1 fashion to either Cardiva Mid-Bore Venous Vascular Closure Device (VVCD) or manual compression for multiple venous access site hemostasis
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiva Mid-Bore VVCS<br>Cardiva Mid-Bore VVCS will be used to close all femoral venous access sites at the end of the case. | Device: Cardiva Mid-Bore VVCS<br>* The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.<br>|
| Active Comparator: Manual Compression<br>Direct manual compression to the access sites will be used to close all femoral venous access sites at the end of the case. | Other: Manual compression<br>* Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Ambulation (TTA) | 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. | Post-procedure, usually within 6 hours | 
| Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event | 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. | 30 +/- 7 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event | Rate of combined minor venous access site closure-related complications. The method used to determine what would be considered minor 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. | 30 +/- 7 days post-procedure | 
| Time to Discharge Eligibility (TTDE) | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is eligible for discharge based solely on assessment of the access site | Prior to hospital discharge, usually within 24 hours | 
| Time to Hemostasis (TTH) | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and first observed and confirmed venous hemostasis, for each access site. | Post-procedure, usually within 3 hours | 
| Time to Discharge (TTD) | Elapsed time between removal of the final Mid-Bore VVCS device (treatment arm) or removal of final sheath (control arm) and when subject is discharged | Prior to hospital discharge, usually within 24 hours | 
| Time to Closure Eligibility (TTCE) | Elapsed time between removal of the last procedural device for the index procedure and removal of the first Mid-Bore VVCS device (treatment arm) or removal of first sheath (control arm) | Post-procedure, usually within 6 hours | 
| Total Post-Procedure Time (TPPT) | Elapsed time between removal of the last procedural device for the index procedure and when the subject is able to successfully ambulate | Post-procedure, usually within 6 hours | 
| Number of Participants With Procedure Success | Attainment of final hemostasis at all venous access sites and freedom from major venous access site closure-related complications | 30 +/- 7 days post-procedure | 
| Number of Access Sites With Device Success | Ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Mid-Bore VVCS (per access site analysis, treatment arm only) | Procedural, usually within 15 minutes of enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple access sites, vessel closure, venous access site, femoral venotomy, medium bore