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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Artery Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

lower extremity PAD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endovascular Treatment of PAD

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PAD endovascular treatment using the DABRA Laser System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jami Miller

Role: STUDY_DIRECTOR

Ra Medical Systems

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NAADI Healthcare

Oklahoma City, Oklahoma, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RMS-104

Identifier Type: -

Identifier Source: org_study_id