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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481741
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : July 31, 2009
Information provided by:
University of Rochester

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Peripheral Vascular Disease Device: SafeSeal(TM) Hemostasis Patch Phase 4

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  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : May 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Primary Outcome Measures :
  1. Time to achieve hemostasis of femoral artery after arterial sheath removal [ Time Frame: immediate ]

Secondary Outcome Measures :
  1. vascular access-related bleeding complications [ Time Frame: prior to hospital discharge ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481741

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Craig R Narins, MD University of Rochester Identifier: NCT00481741     History of Changes
Other Study ID Numbers: RSRB00018198
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: July 31, 2009
Last Verified: July 2009

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
Arterial Occlusive Diseases