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Completed

NCT Number: NCT04241224

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

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

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Key information

Conditions

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

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

California Heart & Vascular Clinic, El Centro, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participants must meet all of the inclusion criteria to participate in this study:

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 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

Treatment and study plan

atherectomy

Device

Endovascular treatment of peripheral arterial disease

Other names: DABRA Laser System

Primary outcomes

  1. Technical Success

    Time frame: At Index Procedure

    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.

  2. Freedom from Major Adverse Events (MAE)

    Time frame: 30 Days

    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).

Secondary outcomes

  1. Incidence of Target Lesion Revascularization (TLR) at 6 months

    Time frame: 6 months

    Clinically driven target lesion revascularization (TLR) at 6 months.

  2. Reduction in Residual Diameter Stenosis

    Time frame: At Index Procedure

    Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.

  3. Rutherford Classification

    Time frame: 30 Days, 6 Months

    Change from baseline in Rutherford Category.

  4. Change in Percent Diameter Stenosis

    Time frame: 30 Days, 6 Months

    Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.

  5. Vessel Patency

    Time frame: 30 Days, 6 Months

    Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.

Sponsors and collaborators

Lead sponsor

Ra Medical Systems

Industry

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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