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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010045
Recruitment Status : Active, not recruiting
First Posted : July 8, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Peripheral Artery Disease 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.

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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : November 30, 2025

Intervention Details:
  • Device: Endovascular Treatment of PAD
    PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.
    Other Name: PAD endovascular treatment using the DABRA Laser System


Primary Outcome Measures :
  1. Vessel Patency [ Time Frame: 24 months ]
    Patency of the target lesion at 24 months, as determined by duplex ultrasound.


Secondary Outcome Measures :
  1. Serious Adverse Events [ Time Frame: 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

  2. Vessel Patency [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population for this study is patients presenting with symptoms of peripheral artery disease.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010045


Locations
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United States, Oklahoma
NAADI Healthcare
Oklahoma City, Oklahoma, United States, 73116
Sponsors and Collaborators
Ra Medical Systems
Investigators
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Study Director: Jami Miller Ra Medical Systems
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Responsible Party: Ra Medical Systems
ClinicalTrials.gov Identifier: NCT04010045    
Other Study ID Numbers: RMS-104
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ra Medical Systems:
lower extremity PAD
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases