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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Atherectomy

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • El Centro, California, United States, 92243
      • California Heart & Vascular Clinic
    • Merced, California, United States, 95340
      • Merced Vein & Vascular Center
  • Florida
    • Gainesville, Florida, United States, 32605
      • The Cardiac & Vascular Institute
    • Hialeah, Florida, United States, 33013
      • Vascardio Heart and Vascular Institute
  • Illinois
    • Chicago, Illinois, United States, 60616
      • MIMIT Health
    • Glen Ellyn, Illinois, United States, 60137
      • MIMIT Health
  • Michigan
    • Roseville, Michigan, United States, 48066
      • Eastlake Cardiovascular
  • Texas
    • Edinburg, Texas, United States, 78539
      • South Texas Vascular Institute
    • Lubbock, Texas, United States, 79430
      • Texas Tech University Health Sciences Center - Center for Cardiovascular Health
    • McAllen, Texas, United States, 78501
      • Laser Surgical Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Participants must meet all of the inclusion criteria to participate in this study:

Inclusion Criteria

1. Ability and willingness to give written informed consent and comply with follow-up requirements
2. PAD with Rutherford Class 2-5
3. Stenotic lesion(s) in the peripheral vasculature
4. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease

Angiographic Inclusion Criteria

1. Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
2. Target vessel ≤ 3.0 mm in diameter
3. Target Lesion ≤ 25cm in length
4. The lesion to be treated is not severely calcified
5. Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
6. No use of another atherectomy device in the same procedure
7. Treatment site is not located in a graft
8. Treatment site is not in, or distal to, a previously placed stent
9. No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device)

Participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation:

Exclusion Criteria

1. Age below 22 years
2. Pregnant, breastfeeding, planning to become pregnant. If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
3. Myocardial infarction (MI) ≤ 60 days prior to procedure
4. Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
5. Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
6. Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
7. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
8. Life expectancy ≤ 12 months
9. Patient is participating in another investigational drug or device study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Excimer Laser Photoablation; Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.	Device: Atherectomy; Endovascular treatment of peripheral arterial disease; Other Names: DABRA Laser System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Ra Medical Systems
• Investigators: Study Chair: Athar Ansari, MD

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): November 17, 2022

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: lower extremity Peripheral Arterial Disease (PAD)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: RMS 103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes