A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04241224|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Atherectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages|
|Actual Study Start Date :||February 26, 2020|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||January 2021|
Experimental: Excimer Laser Photoablation
Device: DABRA Laser System
Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.
Endovascular treatment of peripheral arterial disease
Other Name: DABRA Laser System
- Technical Success [ Time Frame: At Index Procedure ]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.
- Freedom from Major Adverse Events (MAE) [ Time Frame: 30 Days ]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).
- Incidence of Target Lesion Revascularization (TLR) at 6 months [ Time Frame: 6 months ]Clinically driven target lesion revascularization (TLR) at 6 months.
- Reduction in Residual Diameter Stenosis [ Time Frame: At Index Procedure ]Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.
- Rutherford Classification [ Time Frame: 30 Days, 6 Months ]Change from baseline in Rutherford Category.
- Change in Percent Diameter Stenosis [ Time Frame: 30 Days, 6 Months ]Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.
- Vessel Patency [ Time Frame: 30 Days, 6 Months ]Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241224
|Contact: Alicia Sherwoodemail@example.com|
|Contact: Jami Millerfirstname.lastname@example.org|
|United States, California|
|California Heart & Vascular Clinic||Recruiting|
|El Centro, California, United States, 92243|
|Principal Investigator: Athar Ansari, MD|
|United States, Florida|
|Vascardio Heart and Vascular Institute||Recruiting|
|Hialeah, Florida, United States, 33013|
|Principal Investigator: Francisco Dieguez, MD|
|Study Chair:||Athar Ansari, MD|