Clinical trial NCT04010045: REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study
Official title: REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Peripheral Artery Disease
Keywords: lower extremity PAD
Lead sponsor: Ra Medical Systems
Sponsor class: INDUSTRY
First posted: 2019-07-08
Enrollment: 19
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study is patients presenting with symptoms of peripheral artery disease.

Brief summary: This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.
* Ability and willingness of participant to give written informed consent and comply with follow-up.

Exclusion Criteria:

* 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.
* Inability or unwillingness of the patient to comply with study examinations.
* Necrosis necessitating major amputation.
* Subject has an anticipated life span of less than one (1) year.
* Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels).
* No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.

Primary outcomes:
measure: Vessel Patency
timeFrame: 24 months
Secondary outcomes:
measure: Serious Adverse Events
timeFrame: 1 day, 6 months, 12 months, 18 months, and 24 months
measure: Vessel Patency
timeFrame: 6 months, 12 months, and 18 months
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: NAADI Healthcare
state: Oklahoma
Study officials:
affiliation: Ra Medical Systems
name: Jami Miller
role: STUDY_DIRECTOR
References: