Status:
TERMINATED
REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study
Lead Sponsor:
Ra Medical Systems
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
22+ years
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 per...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04010045
Start Date
May 2 2019
End Date
October 15 2020
Last Update
November 3 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NAADI Healthcare
Oklahoma City, Oklahoma, United States, 73116