The purpose of this study is to determine if the CROSSER CTO Recanalization System can facilitate the successful crossing of Chronic Total Occlusions in the Central lumen of the Superficial Femoral Artery (SFA). A Chronic Total Occlusion (CTO) is defined as 100% narrowing of the artery, with no angiographically detectable antegrade blood flow, and the assessment that the lesion has been in existence for a minimum of 30 days. This study will enroll up to 100 patients at up to 8 clinical sites. The CROSSER CTO Recanalization System was cleared for commercialization by the US Food \& Drug Administration. This study also involves an imaging device called the IVUS (Intravascular Ultrasound Imaging) catheter. This device has been cleared for commercialization by the US Food and Drug Administration and will be studied for its cleared intended use. The IVUS catheter is used to generate real-time images of the artery, which will allow for evaluation of the artery after the occlusion is crossed. This is a post-market registry.
Study Type
OBSERVATIONAL
Enrollment
100
The Crosser system will be used to recanalize the chronic total occlusion in the SFA (superficial femoral artery). The IVUS (Intravascular Ultrasound Imaging) System will be used in the treated occlusion after the Crosser to generate real-time images of the artery.
Washington Hospital Center
Washington D.C., District of Columbia, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Mercy Heart and Vascular Center
Coon Rapids, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Memphis Heart Clinic
Memphis, Tennessee, United States
Crosser navigates through the central lumen of the artery
Successful navigation of the CROSSER CTO Recanalization Catheter in the central lumen of the artery as confirmed by Intravascular Ultrasound (IVUS) following recanalization
Time frame: At time of procedure (day 0)
Technical Success - crossing the CTO into the true distal lumen
The ability to facilitate crossing the CTO into the true distal lumen with the CROSSER Catheter and/or any conventional guidewire after use of the CROSSER.
Time frame: At time of procedure (Day 0)
Procedural Success - Technical success plus residual stenosis < 50% and improved flow
Achievement of Technical Success plus a residual stenosis \<50%, and improved flow verified angiographically, at the conclusion of the procedure.
Time frame: Time of Procedure (Day 0)
Clinical Success - freedom from limb loss and repeat revascularization
Clinical Success - freedom from limb loss, and repeat revascularization (bypass surgery, or PTA) from index hospitalization through 6 moth follow-up
Time frame: 6 month follow-up
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