Trials / Completed
CompletedNCT00481741
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.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (actual)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SafeSeal(TM) Hemostasis Patch |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2007-10-01
- Completion
- 2007-12-01
- First posted
- 2007-06-04
- Last updated
- 2009-07-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00481741. Inclusion in this directory is not an endorsement.