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

Cardiva Medical

Status

Completed

Conditions

Surgical Wound

Treatments

Other: Manual compression

Device: Cardiva Mid-Bore VVCS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03193021

PTL 0508

Details and patient eligibility

About

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.

Full 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.

Enrollment

204 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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