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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CROSSER |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1. CROSSER System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At time of procedure (day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At time of procedure (Day 0) |
| Procedural Success - Technical success plus residual stenosis < 50% and improved flow |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with CTO who are indicated for recanalization.
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| Name | Affiliation | Role |
|---|---|---|
| Thomas P. Davis, MD | St. John Hospital & Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Iowa Methodist Medical Center |
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| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
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|
|
Achievement of Technical Success plus a residual stenosis <50%, and improved flow verified angiographically, at the conclusion of the procedure. |
| 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 | 6 month follow-up |
| Des Moines |
| Iowa |
| 50325 |
| United States |
| St. John Hospital and Medical Center | Detroit | Michigan | 48236 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Mercy Heart and Vascular Center | Coon Rapids | Minnesota | 55433 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45243 | United States |
| Memphis Heart Clinic | Memphis | Tennessee | 38120 | United States |