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Vascular access site closure · 1 trial · 2 indications
| Name | Type | Description |
|---|---|---|
| Vascular access site closure (7F Ensure) | DEVICE | - |
Inclusion Criteria: * Scheduled for a coronary diagnostic or interventional procedure * Able to undergo emergent vascular surgery if a complication requires it * 7F arterial puncture located in the common femoral artery * Femoral artery has a lumen diameter of at least 5 mm Exclusion Criteria: * ...
Vascular access site closure is a device-based approach used in percutaneous coronary intervention, including angioplasty and treatment of coronary arteriosclerosis. It is designed to close the arterial access site after these procedures. The system is being studied for its safety and effectiveness in patients undergoing such interventions.
Vascular access site closure is being developed by Cardinal Health, Inc., a company traded on the New York Stock Exchange under the ticker CAH. The company is conducting clinical research on this device for use in cardiovascular procedures.
Vascular access site closure is in Phase 2 clinical development. It is an investigational device and has not been approved by regulatory authorities. The Phase 2 study has been completed, and the device remains under evaluation for its intended use in percutaneous coronary interventions.
Vascular access site closure has one completed clinical trial, identified as NCT00533156, titled "Plug Arterial Closure System (PACS, 7F)". This Phase 2 study enrolled 30 participants in Mexico and evaluated the device in patients with coronary arteriosclerosis undergoing percutaneous coronary angioplasty.
Yes, Vascular access site closure is associated with the Plug Arterial Closure System (PACS), as referenced in the clinical trial NCT00533156. The trial specifically evaluates the PACS in a 7F size for closing arterial access sites after percutaneous coronary procedures.