AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, … (NCT03193021) | Clinical Trial Compass
CompletedNot Applicable
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
United States204 participantsStarted 2017-09-20
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Time to Ambulation (TTA)
Timeframe: Post-procedure, usually within 6 hours
2
Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event