| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00345631 | Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device | PHASE3 | COMPLETED | 488 | — | — | Feb 1, 2007 | Sep 1, 2007 | Jun 1, 2012 | 17 | United States |
Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.
Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.
Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (\> 30 days) access site-related nerve injury.
| Arm | Type | Description |
|---|---|---|
| Manual Compression | ACTIVE_COMPARATOR | Manual compression (MC) |
| Vascular Closure Device | EXPERIMENTAL | Vascular Closure Device (VCD) |
| Name | Type | Description |
|---|---|---|
| Manual Compression | OTHER | Manual compression |
| Vascular Closure Device | DEVICE | Investigational vascular closure device |
Inclusion Criteria: * Scheduled for a coronary or peripheral diagnostic or interventional procedure * Able to undergo emergent vascular surgery if a complication requires it * 6F arterial puncture located in the common femoral artery * Femoral artery has a lumen diameter of at least 5 mm Exclusion...