The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
The study will recruit approximately 600 subjects treated for PAD.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Radiology and Imaging Specialists
Lakeland, Florida, United States
RECRUITINGVital Heart and Vein
Humble, Texas, United States
RECRUITINGProcedural Success
Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.
Time frame: Immediate Post Index Procedure
Freedom from major complications
Freedom from composite of device and/or procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure
Time frame: 30 days post index procedure
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