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NCT03193021 · ClinicalTrials.gov registry record · NA
AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID
A NA study, sponsored by Cardiva Medical.
- Completed
- Registry status
- NA
- Development phase
- 204
- Enrollment target
NCT03193021: Completed NA study, sponsored by Cardiva Medical.
NCT03193021 is a NA study that has completed, run by Cardiva Medical. The registered enrollment target is 204 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03193021, a NA study, has completed, sponsored by Cardiva Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- OTHER Manual compression
- DEVICE Cardiva Mid-Bore VVCS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2017-09-20 |
| Est. Completion | 2018-04-13 |
| Phase | NA |
What the finished NCT03193021 record still lists
NCT03193021 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Manual compression is the first listed.
NCT03193021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03193021 about?
NCT03193021 is a clinical study titled "AMBULATE: Cardiva Mid-Bore VVCS vs. Manual Compression for Multiple Femoral Venous Access Sites, 6 - 12F ID". 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 procedur...
What is the current status of trial NCT03193021?
This trial is currently completed. It is a NA study. The enrollment target is 204 participants. The study started on 2017-09-20. Estimated completion is 2018-04-13.
What interventions are being tested in trial NCT03193021?
The interventions under investigation include: Manual compression (OTHER), Cardiva Mid-Bore VVCS (DEVICE).
Who is sponsoring clinical trial NCT03193021?
This trial is sponsored by Cardiva Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03193021's enrollment target sits among peer trials
204 500th of 2000 higher than 1,497 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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