RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
Public ClinicalTrials.gov record NCT01297322. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Prospective, Randomized, Controlled, Trial to Evaluate the Safety and Efficacy of the Cardiva VASCADE VCS vs. Manual Compression for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01297322
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 420 participants
Conditions and interventions
Conditions
Interventions
Other · Device
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- May 31, 2012
- Completion
- Jun 30, 2012
- Last update posted
- Jan 21, 2020
2011 – 2012
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Thomas Hospital | Fairhope | Alabama | 36532 | — |
| Christiana Care | Newark | Delaware | 19718 | — |
| Holmes Regional Medical Center | Melbourne | Florida | 32901 | — |
| St. John's Prairie Heart | Springfield | Illinois | 62769 | — |
| St. Vincent's Heart Center of Indiana | Indianapolis | Indiana | 46290 | — |
| King's Daughters Medical Center | Ashland | Kentucky | 41101 | — |
| Terrebonne General Medical Center | Houma | Louisiana | 70360 | — |
| Lafayette General Medical Center | Lafayette | Louisiana | 70503 | — |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912 | — |
| Tufts University | Boston | Massachusetts | 02111 | — |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Cooper Health System | Camden | New Jersey | 08012 | — |
| Winthrop University Hospital | Mineola | New York | 11501 | — |
| New York-Presbyterian Hospital | New York | New York | 10065 | — |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | — |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | — |
| Heart Hospital of Austin | Austin | Texas | 78756 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | — |
| CAMC Health Education and Research Institute, Inc. | Charleston | West Virginia | 25304 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01297322, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2020 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01297322 live on ClinicalTrials.gov.