REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

Terminated

• Conditions: Peripheral Artery Disease

• Registration Number: NCT04010045
• Lead Sponsor: Ra Medical Systems

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.

Study Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2019-06-04
• Study First Submitted QC: 2019-07-03
• Study First Posted: 2019-07-08
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vessel Patency	24 months	Patency of the target lesion at 24 months, as determined by duplex ultrasound.

Secondary Outcome Measures

Name	Time	Method
Serious Adverse Events	1 day, 6 months, 12 months, 18 months, and 24 months	Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months
Vessel Patency	6 months, 12 months, and 18 months	Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound.

Trial Locations

Locations (1)

NAADI Healthcare; 🇺🇸 Oklahoma City, Oklahoma, United States