Clinical Trials Directory

Trials / Completed

CompletedNCT01297322

RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
420 (actual)
Sponsor
Cardiva Medical, Inc. · Industry
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Detailed description

A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing femoral arterial access sites and providing reduced times to hemostasis and ambulation compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control ratio.

Conditions

Interventions

TypeNameDescription
OTHERManual compressionStandard of Care
DEVICECardiva VASCADE™ Vascular Closure SystemInvestigational Hemostatic Vascular Closure System

Timeline

Start date
2011-09-01
Primary completion
2012-06-01
Completion
2012-07-01
First posted
2011-02-16
Last updated
2020-01-22
Results posted
2014-10-03

Locations

21 sites across 2 countries: United States, Australia

Source: ClinicalTrials.gov record NCT01297322. Inclusion in this directory is not an endorsement.