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

This study has been completed.
Sponsor:
Collaborator:
MEDRAD, Inc.
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00481741
First received: June 1, 2007
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Peripheral Vascular Disease
 Device: SafeSeal(TM) Hemostasis Patch
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Time to achieve hemostasis of femoral artery after arterial sheath removal [ Time Frame: immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vascular access-related bleeding complications [ Time Frame: prior to hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: May 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481741

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
MEDRAD, Inc.
Investigators
Principal Investigator: Craig R Narins, MD University of Rochester
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00481741     History of Changes
Other Study ID Numbers: RSRB00018198
Study First Received: June 1, 2007
Last Updated: July 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Angioplasty, Percutaneous TransluminalCoronary

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Heart Diseases
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Atherosclerosis
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013