Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
NCT00481741 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2009-07-31
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.
Conditions
- Coronary Artery Disease
- Peripheral Vascular Disease
Interventions
- DEVICE
-
SafeSeal(TM) Hemostasis Patch
Sponsors & Collaborators
-
MEDRAD, Inc.
collaborator INDUSTRY -
University of Rochester
lead OTHER
Principal Investigators
-
Craig R Narins, MD · University of Rochester
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-05-31
- Primary Completion
- 2007-10-31
- Completion
- 2007-12-31
Countries
- United States
Study Locations
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