N/A
N=204
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
Surgical Wound
Bottom Line
View on ClinicalTrials.gov: NCT03193021 ↗Enrolled (actual)
204
Serious AEs
5.4%
Results posted
Feb 2020
Primary outcome: Primary: Time to Ambulation (TTA) — 2.8; 6.1 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiva Mid-Bore VVCS (Device); Manual compression (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cardiva Medical, Inc.
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Ambulation (TTA) |
2.8; 6.1 | — |
| PRIMARY Major Venous Access Site Closure-related Complications, Number of Limbs With Each Event |
0; 0 | — |
| SECONDARY Minor Venous Access Site Closure-related Complications, Number of Limbs With Each Event |
2; 5 | — |
| SECONDARY Time to Discharge Eligibility (TTDE) |
3.1; 6.5 | — |
| SECONDARY Time to Hemostasis (TTH) |
6.1; 13.7 | — |
| SECONDARY Time to Discharge (TTD) |
21.8; 21.8 | — |
| SECONDARY Time to Closure Eligibility (TTCE) |
10.5; 37.6 | — |
| SECONDARY Total Post-Procedure Time (TPPT) |
3.1; 6.8 | — |
| SECONDARY Number of Participants With Procedure Success |
98; 103; 2; 1 | — |
| SECONDARY Number of Access Sites With Device Success |
351 | — |
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.
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 45 kg/m2 or 12 Fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be < 2.5 cm deep
Data sourced from ClinicalTrials.gov (NCT03193021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.