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.

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.