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

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ClinicalTrials.gov Identifier: NCT00481741
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : July 31, 2009
Information provided by:
University of Rochester

June 1, 2007
June 4, 2007
July 31, 2009
May 2007
October 2007   (Final data collection date for primary outcome measure)
Time to achieve hemostasis of femoral artery after arterial sheath removal [ Time Frame: immediate ]
Same as current
Complete list of historical versions of study NCT00481741 on ClinicalTrials.gov Archive Site
vascular access-related bleeding complications [ Time Frame: prior to hospital discharge ]
Same as current
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Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
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.
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.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Peripheral Vascular Disease
Device: SafeSeal(TM) Hemostasis Patch
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2007
October 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Rochester
Principal Investigator: Craig R Narins, MD University of Rochester
University of Rochester
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP