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To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Excimer Laser Photoablation | Experimental | Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atherectomy | Device | Endovascular treatment of peripheral arterial disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory. | At Index Procedure |
| Freedom from Major Adverse Events (MAE) | Primary safety endpoint is freedom from Major Adverse Events, defined as all-cause mortality, unplanned major target limb amputation (at or above the ankle), clinically driven target limb revascularization (CD-TLR) at 30 Days, as classified by the Clinical Events Committee (CEC). | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Target Lesion Revascularization (TLR) at 6 months | Clinically driven target lesion revascularization (TLR) at 6 months. | 6 months |
| Reduction in Residual Diameter Stenosis | Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy. |
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Participants must meet all of the inclusion criteria to participate in this study:
Inclusion Criteria
Angiographic Inclusion Criteria
Participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Athar Ansari, MD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Heart & Vascular Clinic | El Centro | California | 92243 | United States | ||
| Merced Vein & Vascular Center |
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| At Index Procedure |
| Rutherford Classification | Change from baseline in Rutherford Category. | 30 Days, 6 Months |
| Change in Percent Diameter Stenosis | Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory. | 30 Days, 6 Months |
| Vessel Patency | Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory. | 30 Days, 6 Months |
| Merced |
| California |
| 95340 |
| United States |
| The Cardiac & Vascular Institute | Gainesville | Florida | 32605 | United States |
| Vascardio Heart and Vascular Institute | Hialeah | Florida | 33013 | United States |
| MIMIT Health | Chicago | Illinois | 60616 | United States |
| MIMIT Health | Glen Ellyn | Illinois | 60137 | United States |
| Eastlake Cardiovascular | Roseville | Michigan | 48066 | United States |
| South Texas Vascular Institute | Edinburg | Texas | 78539 | United States |
| Texas Tech University Health Sciences Center - Center for Cardiovascular Health | Lubbock | Texas | 79430 | United States |
| Laser Surgical Solutions | McAllen | Texas | 78501 | United States |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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| ID | Term |
|---|---|
| D017073 | Atherectomy |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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