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

NCT04010045 | Terminated FDA Device

• 1 other identifier: RMS-104
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral Artery Disease

Keywords

lower extremity PAD

Outcome Measures

Primary Outcomes (1)

• Vessel Patency

  Patency of the target lesion at 24 months, as determined by duplex ultrasound.

  24 months

Secondary Outcomes (2)

• Serious Adverse Events

  1 day, 6 months, 12 months, 18 months, and 24 months

• Vessel Patency

  6 months, 12 months, and 18 months

Interventions

Endovascular Treatment of PAD DEVICE

PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.

Also known as: PAD endovascular treatment using the DABRA Laser System

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is patients presenting with symptoms of peripheral artery disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ra Medical Systems: lead

Study Sites (1)

NAADI Healthcare

Oklahoma City, Oklahoma, 73116, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jami Miller

  Ra Medical Systems

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 8, 2019
• Study Start: May 2, 2019
• Primary Completion: October 15, 2020
• Study Completion: October 15, 2020
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)