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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-26

Study Completion Date

2022-11-17

Brief Summary

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

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Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Excimer Laser Photoablation

Device: DABRA Laser System

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

Group Type EXPERIMENTAL

Atherectomy

Intervention Type DEVICE

Endovascular treatment of peripheral arterial disease

Interventions

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Atherectomy

Endovascular treatment of peripheral arterial disease

Intervention Type DEVICE

Other Intervention Names

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DABRA Laser System

Eligibility Criteria

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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

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)

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

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No