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Manual Compression, Vascular Closure Device · 1 trial · 3 indications
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...
Manual Compression, Vascular Closure Device is used for patients undergoing angioplasty, transluminal, percutaneous coronary procedures. It is intended for use in conditions including coronary arteriosclerosis and peripheral arteriosclerosis. The device is being studied for its safety and effectiveness in closing vascular access sites after these procedures.
Manual Compression, Vascular Closure Device is developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker symbol CAH. Cardinal Health is the developer of this vascular closure device, which is currently in clinical development for cardiovascular applications.
Manual Compression, Vascular Closure Device is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the device remains under clinical investigation for its intended use in percutaneous coronary procedures.
Manual Compression, Vascular Closure Device has one completed Phase 3 clinical trial, identified as NCT00345631, titled 'Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device.' This randomized, active-controlled study enrolled 488 participants in the United States and included adults aged 18 years and older.
Yes, Manual Compression, Vascular Closure Device is the same as the Ensure Medical Vascular Closure Device. The clinical trial NCT00345631, which studied this device, is titled 'Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device,' confirming that these names refer to the same investigational device.