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

Coronary Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481741
• Other study ID #: RSRB00018198
• Status: Completed
• Phase: Phase 4
• First received: June 1, 2007
• Last updated: July 30, 2009
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: July 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• SafeSeal(TM) Hemostasis Patch

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	MEDRAD, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to achieve hemostasis of femoral artery after arterial sheath removal		immediate	No
Secondary	vascular access-related bleeding complications		prior to hospital discharge	No