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COMPLETED NA

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

NCT01297322 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 420 participants
Start Date 2011-09
Est. Completion 2012-07
Phase NA

Sponsor

Cardiva Medical

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01297322

The ClinicalTrials.gov registry entry for NCT01297322 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 420 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cardiva Medical, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01297322 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Louisiana, New York, Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01297322?

The interventions under investigation include: Manual compression (OTHER), Cardiva VASCADE™ Vascular Closure System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01297322?

This trial is sponsored by Cardiva Medical, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial