Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions

July 30, 2009 updated by: University of Rochester

A Prospective Randomized Controlled Efficacy and Safety Trial of the SafeSeal Hemostasis Patch Compared to Manual Compression for Achieving Vascular Hemostasis Following Percutaneous Coronary and Peripheral Intervention.

We seek to determine if the use of the SafeSeal(TM) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention. We further seek to assess the safety of the SafeSeal patch compared to manual compression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A variety of topical hemostasis pads containing procoagulant materials are currently available to accelerate hemostasis after removal of the arterial introducer sheath following coronary and peripheral arterial angioplasty procedures. The effectiveness and safety of these pads, however, remains poorly understood. A total of 150 patients undergoing coronary or peripheral vascular angioplasty through a 6 French arterial sheath will be randomized to sheath removal using manual compression alone or manual compression combined with use of the SafeSeal(TM) hemostasis patch. Sheaths will be removed at an activated clotting time (ACT) of <250 seconds, and patients will be kept at bedrest for 2 hours after hemostasis is achieved. The primary endpoint will be time to hemostasis. Secondary endpoints witll include time to ambulation and frequency of bleeding complications.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient ≥ 18 years old
  2. Coronary or peripheral vascular intervention
  3. 6 French arterial sheath used
  4. Overnight hospitalization following procedure

Exclusion Criteria:

  1. Hematoma or persistent bleeding around the vascular sheath
  2. Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery
  3. History of bleeding diathesis or coagulopathy
  4. Hemoglobin level < 9 g/dl
  5. Inability to ambulate at baseline
  6. Known allergy to any of the materials used in the SafeSeal
  7. Female patients known to be pregnant or lactating
  8. Evidence of ongoing systemic or cutaneous infection
  9. Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110)
  10. Current enrolment in another ongoing investigational drug/device trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to achieve hemostasis of femoral artery after arterial sheath removal
Time Frame: immediate
immediate

Secondary Outcome Measures

Outcome Measure
Time Frame
vascular access-related bleeding complications
Time Frame: prior to hospital discharge
prior to hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Collaborators

MEDRAD, Inc.

Investigators

  • Principal Investigator: Craig R Narins, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

June 1, 2007

First Submitted That Met QC Criteria

June 1, 2007

First Posted (Estimate)

June 4, 2007

Study Record Updates

Last Update Posted (Estimate)

July 31, 2009

Last Update Submitted That Met QC Criteria

July 30, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSRB00018198

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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