Clinical trial NCT04241224: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: lower extremity Peripheral Arterial Disease (PAD)
Lead sponsor: Ra Medical Systems
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 108
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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 2-5
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% and ≤100% by angiography (as determined by Investigator)
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) as applicable depending on access
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

Primary outcomes:
measure: Technical Success
timeFrame: At Index Procedure
measure: Freedom from Major Adverse Events (MAE)
timeFrame: 30 Days
Secondary outcomes:
measure: Incidence of Target Lesion Revascularization (TLR) at 6 months
timeFrame: 6 months
measure: Reduction in Residual Diameter Stenosis
timeFrame: At Index Procedure
measure: Rutherford Classification
timeFrame: 30 Days, 6 Months
measure: Change in Percent Diameter Stenosis
timeFrame: 30 Days, 6 Months
measure: Vessel Patency
timeFrame: 30 Days, 6 Months
Other outcomes:
Locations:
city: El Centro
country: United States
facility: California Heart & Vascular Clinic
state: California
city: Merced
country: United States
facility: Merced Vein & Vascular Center
state: California
city: Gainesville
country: United States
facility: The Cardiac & Vascular Institute
state: Florida
city: Hialeah
country: United States
facility: Vascardio Heart and Vascular Institute
state: Florida
city: Chicago
country: United States
facility: MIMIT Health
state: Illinois
city: Glen Ellyn
country: United States
facility: MIMIT Health
state: Illinois
city: Roseville
country: United States
facility: Eastlake Cardiovascular
state: Michigan
city: Edinburg
country: United States
facility: South Texas Vascular Institute
state: Texas
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center - Center for Cardiovascular Health
state: Texas
city: McAllen
country: United States
facility: Laser Surgical Solutions
state: Texas
Study officials:
name: Athar Ansari, MD
role: STUDY_CHAIR
References: