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

NCT01297322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2020-01-22

Study results available
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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.

Conditions

  • Surgical Wound

Interventions

OTHER

Manual compression

Standard of Care

DEVICE

Cardiva VASCADE™ Vascular Closure System

Investigational Hemostatic Vascular Closure System

Sponsors & Collaborators

  • Cardiva Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • James B. Hermiller, Jr., MD, FACC · The St. Vincent Heart Center of Indiana, St. Vincent Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297322 on ClinicalTrials.gov