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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241224
• Other study ID #: RMS 103
• Status: Completed
• Phase: N/A
• Start date: February 26, 2020
• Est. completion date: November 17, 2022

Study information

• Verified date: January 2023
• Source: Ra Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 17, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Atherectomy
Endovascular treatment of peripheral arterial disease

Locations

Country	Name	City	State
United States	MIMIT Health	Chicago	Illinois
United States	South Texas Vascular Institute	Edinburg	Texas
United States	California Heart & Vascular Clinic	El Centro	California
United States	The Cardiac & Vascular Institute	Gainesville	Florida
United States	MIMIT Health	Glen Ellyn	Illinois
United States	Vascardio Heart and Vascular Institute	Hialeah	Florida
United States	Texas Tech University Health Sciences Center - Center for Cardiovascular Health	Lubbock	Texas
United States	Laser Surgical Solutions	McAllen	Texas
United States	Merced Vein & Vascular Center	Merced	California
United States	Eastlake Cardiovascular	Roseville	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ra Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Index Procedure
Primary	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).	30 Days
Secondary	Incidence of Target Lesion Revascularization (TLR) at 6 months	Clinically driven target lesion revascularization (TLR) at 6 months.	6 months
Secondary	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.	At Index Procedure
Secondary	Rutherford Classification	Change from baseline in Rutherford Category.	30 Days, 6 Months
Secondary	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.	30 Days, 6 Months
Secondary	Vessel Patency	Vessel patency as measured by Doppler ultrasound and assessed by an independent core laboratory.	30 Days, 6 Months