RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
Completed · Not applicable
Conditions studied: Surgical Wound
In brief
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.
Key facts
- Study ID
- NCT01297322
- Run by
- Cardiva Medical, Inc.
- People needed
- 420
- Starts
- 2011-09-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2020-01-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Thomas Hospital — Fairhope, Alabama, United States
- Christiana Care — Newark, Delaware, United States
- Holmes Regional Medical Center — Melbourne, Florida, United States
- St. John's Prairie Heart — Springfield, Illinois, United States
- St. Vincent's Heart Center of Indiana — Indianapolis, Indiana, United States
- King's Daughters Medical Center — Ashland, Kentucky, United States
- Terrebonne General Medical Center — Houma, Louisiana, United States
- Lafayette General Medical Center — Lafayette, Louisiana, United States
- Washington Adventist Hospital — Takoma Park, Maryland, United States
- Tufts University — Boston, Massachusetts, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
- Cooper Health System — Camden, New Jersey, United States
- Winthrop University Hospital — Mineola, New York, United States
- New York-Presbyterian Hospital — New York, New York, United States
- Forsyth Medical Center — Winston-Salem, North Carolina, United States
- Oklahoma Heart Institute — Tulsa, Oklahoma, United States
- Heart Hospital of Austin — Austin, Texas, United States
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States
- Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
- CAMC Health Education and Research Institute, Inc. — Charleston, West Virginia, United States
- St. Vincent's Hospital Melbourne — Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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