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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2023
  • participants needed
    125
  • sponsor
    Ra Medical Systems
Updated on 10 April 2022
arteriopathy
luminal
angiography
stenosis
stenotic
atherectomy
peripheral arterial diseases

Summary

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

Details
Condition Peripheral Arterial Disease
Treatment atherectomy
Clinical Study IdentifierNCT04241224
SponsorRa Medical Systems
Last Modified on10 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Patient is participating in another investigational drug or device study
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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