A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Atherectomy

• Registration Number: NCT04241224
• Lead Sponsor: Ra Medical Systems

Brief Summary

To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Study Start: 2020-02-26
• Primary Completion: 2022-05-31
• Study Completion: 2022-11-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Excimer Laser Photoablation	Atherectomy	Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.

Primary Outcome Measures

Name	Time	Method
Technical Success	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)	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of Target Lesion Revascularization (TLR) at 6 months	6 months	Clinically driven target lesion revascularization (TLR) at 6 months.
Vessel Patency	30 Days, 6 Months	Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Reduction in Residual Diameter Stenosis	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	30 Days, 6 Months	Change from baseline in Rutherford Category.
Change in Percent Diameter Stenosis	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.

Trial Locations

Locations (9)

Eastlake Cardiovascular; 🇺🇸 Roseville, Michigan, United States

Merced Vein & Vascular Center; 🇺🇸 Merced, California, United States

Vascardio Heart and Vascular Institute; 🇺🇸 Hialeah, Florida, United States

South Texas Vascular Institute; 🇺🇸 Edinburg, Texas, United States

California Heart & Vascular Clinic; 🇺🇸 El Centro, California, United States

MIMIT Health; 🇺🇸 Glen Ellyn, Illinois, United States

Laser Surgical Solutions; 🇺🇸 McAllen, Texas, United States

Texas Tech University Health Sciences Center - Center for Cardiovascular Health; 🇺🇸 Lubbock, Texas, United States

The Cardiac & Vascular Institute; 🇺🇸 Gainesville, Florida, United States