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

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

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

Study Overview

• Status: Terminated
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: Endovascular Treatment of PAD

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 Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • NAADI Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vessel Patency	Patency of the target lesion at 24 months, as determined by duplex ultrasound.	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ra Medical Systems
• Investigators: Study Director: Jami Miller, Ra Medical Systems

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: July 3, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: lower extremity PAD
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: RMS-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes