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

Ra Medical Systems

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Atherectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04241224

RMS 103

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Excimer Laser Photoablation

Experimental group

Description:

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

Treatment:

Device: Atherectomy