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出境医 / 临床实验 / 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)

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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.


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 4, 2019
First Posted Date July 8, 2019
Last Update Posted Date September 9, 2020
Actual Study Start Date May 2, 2019
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2019) 		Vessel Patency [ Time Frame: 24 months ]
Patency of the target lesion at 24 months, as determined by duplex ultrasound.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 3, 2019)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study
Official Title REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study (RESULTS)
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target population for this study is patients presenting with symptoms of peripheral artery disease.
Condition Peripheral Artery Disease
Intervention 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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: July 3, 2019) 		2500
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 30, 2025
Estimated Primary Completion Date November 30, 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04010045
Other Study ID Numbers RMS-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
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.
Responsible Party Ra Medical Systems
Study Sponsor Ra Medical Systems
Collaborators Not Provided
Investigators
Study Director: Jami Miller Ra Medical Systems
PRS Account Ra Medical Systems
Verification Date September 2020

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