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NCT01297322 · ClinicalTrials.gov registry record · NA
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
A NA study of Surgical Wound, sponsored by Cardiva Medical.
- Completed
- Registry status
- NA
- Development phase
- 420
- Enrollment target
- 20
- Study locations
NCT01297322: Completed NA study of Surgical Wound, sponsored by Cardiva Medical.
NCT01297322 is a NA study of Surgical Wound that has completed, run by Cardiva Medical. The registered enrollment target is 420 participants, above the 71-participant average among 17 other Surgical Wound trials with a reported enrollment target (492% higher). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01297322, a NA study of Surgical Wound, has completed, sponsored by Cardiva Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
Primary Outcome
Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Conditions Studied
Interventions
- OTHER Manual compression
- DEVICE Cardiva VASCADE™ Vascular Closure System
Study Locations (20)
Louisiana
- Terrebonne General Medical Center - Houma
- Lafayette General Medical Center - Lafayette
New York
- Winthrop University Hospital - Mineola
- New York-Presbyterian Hospital - New York
Virginia
- Sentara Norfolk General Hospital - Norfolk
- Virginia Commonwealth University Medical Center - Richmond
Alabama
- Thomas Hospital - Fairhope
Delaware
- Christiana Care - Newark
Florida
- Holmes Regional Medical Center - Melbourne
Illinois
- St. John's Prairie Heart - Springfield
Indiana
- St. Vincent's Heart Center of Indiana - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-07 |
| Phase | NA |
What the finished NCT01297322 record still lists
NCT01297322 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, above the 71-participant average among 17 other Surgical Wound trials with a reported enrollment target (492% higher).
The record links to 1 condition, with Surgical Wound appearing as the primary indexed condition, and to 2 interventions - of which Manual compression is the first listed.
NCT01297322 names 20 study sites across 17 states, led by Louisiana, New York, Virginia.
Frequently Asked Questions
What is clinical trial NCT01297322 about?
NCT01297322 is a clinical study titled "RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)". The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than m...
What is the current status of trial NCT01297322?
This trial is currently completed. It is a NA study. The enrollment target is 420 participants. The study started on 2011-09. Estimated completion is 2012-07.
What conditions does trial NCT01297322 study?
This clinical trial studies the following conditions: Surgical Wound.
What interventions are being tested in trial NCT01297322?
The interventions under investigation include: Manual compression (OTHER), Cardiva VASCADE™ Vascular Closure System (DEVICE).
Who is sponsoring clinical trial NCT01297322?
This trial is sponsored by Cardiva Medical, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01297322 being conducted?
This trial has 20 study locations across Alabama, Delaware, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgical Wound
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01297322's enrollment target sits among peer trials
420 1st of 17 higher than 17 of 17 other Surgical Wound trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgical Wound 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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