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A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241224
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ra Medical Systems

Brief Summary:
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Atherectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
Actual Study Start Date : February 26, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Excimer Laser Photoablation

Device: DABRA Laser System

Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.

Device: Atherectomy
Endovascular treatment of peripheral arterial disease
Other Name: DABRA Laser System




Primary Outcome Measures :
  1. Technical Success [ Time Frame: At Index Procedure ]
    The Primary Efficacy Endpoint is the mean reduction in percent diameter stenosis in each subject's primary lesion following treatment with the DABRA Laser System and before any other treatment, as assessed by an independent Angiographic Core Laboratory.

  2. Freedom from Major Adverse Events (MAE) [ Time Frame: 30 Days ]
    Primary safety endpoint is freedom from Major Adverse Events, defined as all-cause mortality, unplanned major target limb amputation (at or above the ankle), clinically driven target limb revascularization (CD-TLR) at 30 Days, as classified by the Clinical Events Committee (CEC).


Secondary Outcome Measures :
  1. Incidence of Target Lesion Revascularization (TLR) at 6 months [ Time Frame: 6 months ]
    Clinically driven target lesion revascularization (TLR) at 6 months.

  2. Reduction in Residual Diameter Stenosis [ Time Frame: At Index Procedure ]
    Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.

  3. Rutherford Classification [ Time Frame: 30 Days, 6 Months ]
    Change from baseline in Rutherford Category.

  4. Change in Percent Diameter Stenosis [ Time Frame: 30 Days, 6 Months ]
    Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.

  5. Vessel Patency [ Time Frame: 30 Days, 6 Months ]
    Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participants must meet all of the inclusion criteria to participate in this study:

Inclusion Criteria

  1. Ability and willingness to give written informed consent and comply with follow-up requirements
  2. PAD with Rutherford Class 2-4
  3. Stenotic lesion(s) in the peripheral vasculature
  4. Subject is a candidate for atherectomy for infrainguinal peripheral artery disease

Angiographic Inclusion Criteria

  1. Target vessel with documented stenosis by angiography ≥70%
  2. Target vessel ≤ 3.0 mm in diameter
  3. Target Lesion ≤ 25cm in length
  4. The lesion to be treated is not severely calcified
  5. Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion)
  6. No use of another atherectomy device in the same procedure
  7. Treatment site is not located in a graft
  8. Treatment site is not in, or distal to, a previously placed stent
  9. No flow limiting dissection proximal, distal, or in the target lesion (prior to the use of the investigational device)

Participants meeting any of the exclusion criteria at the time of enrollment (index procedure/ intervention) will be excluded from study participation:

Exclusion Criteria

  1. Age below 22 years
  2. 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.
  3. Myocardial infarction (MI) ≤ 60 days prior to procedure
  4. Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
  5. Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
  6. Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
  7. Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
  8. Life expectancy ≤ 12 months
  9. Patient is participating in another investigational drug or device study

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): NCT04241224


Contacts
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Contact: Alicia Sherwood 442-244-4061 asherwood@ramed.com
Contact: Jami Miller 442-244-4672 jmiller@ramed.com

Locations
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United States, California
California Heart & Vascular Clinic Recruiting
El Centro, California, United States, 92243
Contact    760-353-3222      
Principal Investigator: Athar Ansari, MD         
United States, Florida
Vascardio Heart and Vascular Institute Recruiting
Hialeah, Florida, United States, 33013
Contact    305-575-1776      
Principal Investigator: Francisco Dieguez, MD         
Sponsors and Collaborators
Ra Medical Systems
Investigators
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Study Chair: Athar Ansari, MD
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Responsible Party: Ra Medical Systems
ClinicalTrials.gov Identifier: NCT04241224    
Other Study ID Numbers: RMS 103
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Ra Medical Systems:
lower extremity Peripheral Arterial Disease (PAD)
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases