Suspended
RESULTSREvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
What is being collected
Data Collection
Collected from today forward - ProspectiveWho is being recruted
Arterial Occlusive Diseases+4
+ Arteriosclerosis
+ Cardiovascular Diseases
Over 22 Years
+14 Eligibility Criteria
How is the trial designed
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Observational
Study Start: May 2019
Summary
Principal SponsorRa Medical Systems
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 2, 2019
Actual date on which the first participant was enrolled.This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease. This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.
Official TitleREvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
Principal SponsorRa Medical Systems
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
19 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 22 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesPeripheral Vascular DiseasesAtherosclerosisPeripheral Arterial Disease
Criteria
5 inclusion criteria required to participate
Participant's age ≥ 22 years.
Participant presents with a Rutherford category of 2 to 6.
Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System.
Participant is able and willing to be anti-coagulated.
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9 exclusion criteria prevent from participating
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.
Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
SuspendedOne Study Center