Clinical event adjudication: Peripheral arterial revascularization procedure

For the list of clinical event adjudication definitions, click here Editors-in-Chief: C. Michael Gibson, M.S., M.D. [mailto:mgibson@perfuse.org]

=Peripheral arterial revascularization procedure= This chapter presents peripheral arterial revascularization procedure definitions used in the Clinical Event Committee adjudication processes. These definitions are current as of 3/26/10.

1. Definition of Peripheral Arterial Revascularization Procedure
A peripheral arterial revascularization procedure is a catheter-based or open surgical procedure designed to improve peripheral arterial blood flow. This procedure may include thrombectomy, embolectomy, aneurysm/dissection repair, angioplasty, and stent placement. The intention to perform percutaneous peripheral arterial intervention is denoted by the insertion of a guidewire through a guide catheter into a peripheral artery. The target vessel(s) should be specified (e.g., carotid, vertebral, aorta, renal, iliac, femoral) and recorded as well as the type of revascularization procedure (e.g., surgical, angioplasty, stent placement, thromboembolectomy, aneurysm repair).

2. Procedural Success
In the case of percutaneous intervention for obstructive lesions, procedural success is defined as the achievement of a final residual diameter stenosis < 30% by angiography at the end of the procedure without any in-hospital major adverse events (death, acute onset of limb ischemia, need for urgent/emergent vascular surgery). The balloon inflation and/or stent placement may be preceded by device activation (e.g., angiojet, directional or rotational atherectomy, lasers).

3. Elective and Non-elective Procedures
 Elective : An elective procedure is one that is scheduled and is performed on a patient with stable peripheral arterial disease.

 Non-elective : A non-elective procedure is one that is performed immediately upon diagnosis because of urgency of the medical condition (e.g., acute limb ischemia, acute stroke, acute aortic dissection, acute aneurysm rupture).

4. Target Vessel
A target vessel is any vessel (e.g., carotid, peripheral artery, mesenteric/renal artery) that contains the target lesion treated with the study device. The target vessel includes the target lesion as well as segments of the vessel that are upstream and downstream to the target lesion, including side branches (native vessel).

5. Non-target Vessel
A non-target vessel is one for which revascularization is not attempted or one is which revascularization is performed using a non-study device.