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

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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

Key facts

Study ID

NCT04241224

Run by

Ra Medical Systems

People needed

108

Starts

2020-02-26

Expected to finish

2022-11-17

Last updated by the study team

2023-01-17

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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

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

Where it is running

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

Full record on ClinicalTrials.gov

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