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

NCT04241224 | Completed DMC FDA Device

• 1 other identifier: RMS 103
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Peripheral Arterial Disease

Keywords

lower extremity Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Incidence of Target Lesion Revascularization (TLR) at 6 months

  6 months

• Reduction in Residual Diameter Stenosis

  At Index Procedure

• Rutherford Classification

  30 Days, 6 Months

• Change in Percent Diameter Stenosis

  30 Days, 6 Months

• Vessel Patency

  30 Days, 6 Months

Study Arms (1)

Excimer Laser Photoablation

EXPERIMENTAL

Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.

Device: Atherectomy

Interventions

Atherectomy DEVICE

Endovascular treatment of peripheral arterial disease

Also known as: DABRA Laser System

Excimer Laser Photoablation

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to give written informed consent and comply with follow-up requirements
• PAD with Rutherford Class 2-5
• Stenotic lesion(s) in the peripheral vasculature
• Subject is a candidate for atherectomy for infrainguinal peripheral artery disease
• Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
• Target vessel ≤ 3.0 mm in diameter
• Target Lesion ≤ 25cm in length
• The lesion to be treated is not severely calcified
• Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
• No use of another atherectomy device in the same procedure
• Treatment site is not located in a graft
• Treatment site is not in, or distal to, a previously placed stent
• No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device)

You may not qualify if:

• Age below 22 years
• 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.
• Myocardial infarction (MI) ≤ 60 days prior to procedure
• Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
• Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
• Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
• Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
• Life expectancy ≤ 12 months
• Patient is participating in another investigational drug or device study

Sponsors & Collaborators

• Ra Medical Systems: lead

Study Sites (10)

California Heart & Vascular Clinic

El Centro, California, 92243, United States

Location

Merced Vein & Vascular Center

Merced, California, 95340, United States

Location

The Cardiac & Vascular Institute

Gainesville, Florida, 32605, United States

Location

Vascardio Heart and Vascular Institute

Hialeah, Florida, 33013, United States

Location

MIMIT Health

Chicago, Illinois, 60616, United States

Location

MIMIT Health

Glen Ellyn, Illinois, 60137, United States

Location

Eastlake Cardiovascular

Roseville, Michigan, 48066, United States

Location

South Texas Vascular Institute

Edinburg, Texas, 78539, United States

Location

Texas Tech University Health Sciences Center - Center for Cardiovascular Health

Lubbock, Texas, 79430, United States

Location

Laser Surgical Solutions

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Atherectomy

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Athar Ansari, MD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: February 26, 2020
• Primary Completion: May 31, 2022
• Study Completion: November 17, 2022
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)