Back to resultsA Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atherectomy
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring lower extremity Peripheral Arterial Disease (PAD)
Eligibility Criteria
Participants must meet all of the inclusion criteria to participate in this study:
Inclusion Criteria
- Ability and willingness to give written informed consent and comply with follow-up requirements
- PAD with Rutherford Class 2-5
- Stenotic lesion(s) in the peripheral vasculature
- Subject is a candidate for atherectomy for infrainguinal peripheral artery disease
Angiographic Inclusion Criteria
- Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
- Target vessel ≤ 3.0 mm in diameter
- Target Lesion ≤ 25cm in length
- The lesion to be treated is not severely calcified
- Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
- No use of another atherectomy device in the same procedure
- Treatment site is not located in a graft
- Treatment site is not in, or distal to, a previously placed stent
- 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
- Age below 22 years
- 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.
- Myocardial infarction (MI) ≤ 60 days prior to procedure
- Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
- Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
- Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
- Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
- Life expectancy ≤ 12 months
- Patient is participating in another investigational drug or device study
Sites / Locations
- California Heart & Vascular Clinic
- Merced Vein & Vascular Center
- The Cardiac & Vascular Institute
- Vascardio Heart and Vascular Institute
- MIMIT Health
- MIMIT Health
- Eastlake Cardiovascular
- South Texas Vascular Institute
- Texas Tech University Health Sciences Center - Center for Cardiovascular Health
- Laser Surgical Solutions
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Excimer Laser Photoablation
Arm Description
Device: DABRA Laser System Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.
Outcomes
Primary Outcome Measures
Technical Success
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.
Freedom from Major Adverse Events (MAE)
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
Incidence of Target Lesion Revascularization (TLR) at 6 months
Clinically driven target lesion revascularization (TLR) at 6 months.
Reduction in Residual Diameter Stenosis
Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.
Rutherford Classification
Change from baseline in Rutherford Category.
Change in Percent Diameter Stenosis
Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.
Vessel Patency
Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04241224
Brief Title
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
Official Title
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ra Medical Systems
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of the DABRA Laser System in the atherectomy of peripheral vascular stenoses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
lower extremity Peripheral Arterial Disease (PAD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Excimer Laser Photoablation
Arm Type
Experimental
Arm Description
Device: DABRA Laser System
Patients with symptomatic peripheral vascular disease undergoing an endovascular revascularization procedure utilizing the DABRA Laser System.
Intervention Type
Device
Intervention Name(s)
Atherectomy
Other Intervention Name(s)
DABRA Laser System
Intervention Description
Endovascular treatment of peripheral arterial disease
Primary Outcome Measure Information:
Title
Technical Success
Description
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.
Time Frame
At Index Procedure
Title
Freedom from Major Adverse Events (MAE)
Description
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).
Time Frame
30 Days
Secondary Outcome Measure Information:
Title
Incidence of Target Lesion Revascularization (TLR) at 6 months
Description
Clinically driven target lesion revascularization (TLR) at 6 months.
Time Frame
6 months
Title
Reduction in Residual Diameter Stenosis
Description
Incidence of achieving a residual diameter percent stenosis of ≤ 50% in the primary lesion on the day of treatment, prior to any adjunctive therapy.
Time Frame
At Index Procedure
Title
Rutherford Classification
Description
Change from baseline in Rutherford Category.
Time Frame
30 Days, 6 Months
Title
Change in Percent Diameter Stenosis
Description
Percent diameter stenosis and change from baseline in percent diameter stenosis as measured by Doppler Ultrasound and assessed by an independent core laboratory.
Time Frame
30 Days, 6 Months
Title
Vessel Patency
Description
Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.
Time Frame
30 Days, 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participants must meet all of the inclusion criteria to participate in this study:
Inclusion Criteria
Ability and willingness to give written informed consent and comply with follow-up requirements
PAD with Rutherford Class 2-5
Stenotic lesion(s) in the peripheral vasculature
Subject is a candidate for atherectomy for infrainguinal peripheral artery disease
Angiographic Inclusion Criteria
Target vessel with documented stenosis by angiography ≥70% and ≤100% by angiography (as determined by Investigator)
Target vessel ≤ 3.0 mm in diameter
Target Lesion ≤ 25cm in length
The lesion to be treated is not severely calcified
Untreated ipsilateral iliac stenosis ≤70% (or tortuosity that might prevent advancing sheath to lesion) as applicable depending on access
No use of another atherectomy device in the same procedure
Treatment site is not located in a graft
Treatment site is not in, or distal to, a previously placed stent
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
Age below 22 years
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.
Myocardial infarction (MI) ≤ 60 days prior to procedure
Cerebrovascular Accident (CVA) ≤ 60 days prior to procedure
Endovascular or surgical procedure ≤ 30 Days prior to procedure or a planned endovascular or surgical procedure within 30 days after the index procedure
Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast
Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated
Life expectancy ≤ 12 months
Patient is participating in another investigational drug or device study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athar Ansari, MD
Official's Role
Study Chair
Facility Information:
Facility Name
California Heart & Vascular Clinic
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Merced Vein & Vascular Center
City
Merced
State/Province
California
ZIP/Postal Code
95340
Country
United States
Facility Name
The Cardiac & Vascular Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Vascardio Heart and Vascular Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
MIMIT Health
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
MIMIT Health
City
Glen Ellyn
State/Province
Illinois
ZIP/Postal Code
60137
Country
United States
Facility Name
Eastlake Cardiovascular
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
South Texas Vascular Institute
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78539
Country
United States
Facility Name
Texas Tech University Health Sciences Center - Center for Cardiovascular Health
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Laser Surgical Solutions
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Prospective, Multicenter Atherectomy Study Showing Luminal Gain in Subjects With Peripheral Vascular Blockages
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