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NCT00345631 · ClinicalTrials.gov registry record · Phase 3
Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device
A Phase 3 study, sponsored by Cordis US.
- Completed
- Registry status
- Phase 3
- Development phase
- 488
- Enrollment target
NCT00345631: Completed Phase 3 study, sponsored by Cordis US.
NCT00345631 is a Phase 3 study that has completed, run by Cordis US. The registered enrollment target is 488 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00345631, a Phase 3 study, has completed, sponsored by Cordis US.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 488 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level of safety.
Primary Outcome
Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.
Interventions
- OTHER Manual Compression
- DEVICE Vascular Closure Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 488 participants |
| Start Date | 2007-02 |
| Est. Completion | 2007-09 |
| Phase | Phase 3 |
What the finished NCT00345631 record still lists
NCT00345631 is an interventional study that assigns participants to a tested intervention. The registered 488 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Manual Compression is the first listed.
NCT00345631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00345631 about?
NCT00345631 is a clinical study titled "Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device". The purpose of this study is to determine whether the Ensure Medical Vascular Closure Device is more effective than standard manual compression at sealing the puncture made in the femoral artery following a cardiac or peripheral diagnostic or interventional procedure while maintaining the same level...
What is the current status of trial NCT00345631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 488 participants. The study started on 2007-02. Estimated completion is 2007-09.
What interventions are being tested in trial NCT00345631?
The interventions under investigation include: Manual Compression (OTHER), Vascular Closure Device (DEVICE).
Who is sponsoring clinical trial NCT00345631?
This trial is sponsored by Cordis US, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00345631's enrollment target sits among peer trials
488 784th of 2000 higher than 1,215 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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