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

Completed · Phase 4

Conditions studied: Coronary Artery Disease, Peripheral Vascular Disease

In brief

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.

Key facts

Study ID

NCT00481741

Run by

University of Rochester

People needed

150

Starts

2007-05-01

Expected to finish

2007-12-01

Last updated by the study team

2009-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient ≥ 18 years old
• Coronary or peripheral vascular intervention
• 6 French arterial sheath used
• Overnight hospitalization following procedure

You may not qualify if…

• 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.

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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