Back to resultsStudy of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
Primary Purpose
Coronary Artery Disease, Peripheral Vascular Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
SafeSeal(TM) Hemostasis Patch
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Angioplasty, Percutaneous TransluminalCoronary
Eligibility Criteria
Inclusion Criteria:
- Patient ≥ 18 years old
- Coronary or peripheral vascular intervention
- 6 French arterial sheath used
- Overnight hospitalization following procedure
Exclusion Criteria:
- Hematoma or persistent bleeding around the vascular sheath
- Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery
- History of bleeding diathesis or coagulopathy
- Hemoglobin level < 9 g/dl
- Inability to ambulate at baseline
- Known allergy to any of the materials used in the SafeSeal
- Female patients known to be pregnant or lactating
- Evidence of ongoing systemic or cutaneous infection
- Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110)
- Current enrolment in another ongoing investigational drug/device trial.
Sites / Locations
- University of Rochester Medical Center
Outcomes
Primary Outcome Measures
Time to achieve hemostasis of femoral artery after arterial sheath removal
Secondary Outcome Measures
vascular access-related bleeding complications
Full Information
NCT ID
NCT00481741
First Posted
June 1, 2007
Last Updated
July 30, 2009
Sponsor
University of Rochester
Collaborators
MEDRAD, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00481741
Brief Title
Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
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 Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Rochester
Collaborators
MEDRAD, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Peripheral Vascular Disease
Keywords
Angioplasty, Percutaneous TransluminalCoronary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
SafeSeal(TM) Hemostasis Patch
Primary Outcome Measure Information:
Title
Time to achieve hemostasis of femoral artery after arterial sheath removal
Time Frame
immediate
Secondary Outcome Measure Information:
Title
vascular access-related bleeding complications
Time Frame
prior to hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥ 18 years old
Coronary or peripheral vascular intervention
6 French arterial sheath used
Overnight hospitalization following procedure
Exclusion Criteria:
Hematoma or persistent bleeding around the vascular sheath
Previous AV fistula or pseudoaneurysm in the ipsilateral femoral artery
History of bleeding diathesis or coagulopathy
Hemoglobin level < 9 g/dl
Inability to ambulate at baseline
Known allergy to any of the materials used in the SafeSeal
Female patients known to be pregnant or lactating
Evidence of ongoing systemic or cutaneous infection
Uncontrolled blood pressure following PCI (systolic blood pressure > 180 or diastolic blood pressure >110)
Current enrolment in another ongoing investigational drug/device trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig R Narins, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of the SafeSeal(TM) Hemostasis Patch Following Percutaneous Coronary Artery and Peripheral Vascular Interventions
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