Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease

A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease

The purpose of this study is to evaluate the safety and efficacy of an excimer laser in the treatment of patients with lower extremity vascular disease with chronic total occlusions.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: RA-308 Excimer Laser and DABRA Catheter

Detailed Description

The study is a multi center, prospective, non-randomized, open-label study conducted at a minimum of one investigational center. 50 subjects can be enrolled. Follow-up occurs at the end of the procedure in the form of an angiogram to determine if the lesion was crossed. Additional follow-up may not necessary because of the binary nature of the crossing, and also because any future follow-up would be assessing the effectiveness of adjunct therapy, e.g. balloon angioplasty. Long term results are entirely dependent on this subsequent treatment. Because the DABRA crosser only allows adjunct devices to be used, 30-day follow-up measuring the performance of the adjunct therapy might affect the physician's choice of therapy, and compromise the patient's treatment. Therefore, 30-day follow-up, which evaluates the effectiveness of the adjunct therapy, might raise ethical concerns. However, the follow-up can be done by Ankle-Brachial Index, Doppler ultrasound, auscultation, or by discussion of the level of claudication and motion pain with the patient. To evaluate the safety and efficacy of the RA-308 Excimer Laser System and DABRA Catheter for treating subjects with symptomatic infrainguinal lower extremity vascular disease with chronic total occlusions that cannot be crossed with standard guide wires, or lesions where an attempt to cross would, in the opinion of the interventionalist, result in either a subintimal path or a perforation.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • El Centro, California, United States, 92243
      • California Heart & Vascular Clinic
    • San Diego, California, United States, 92093
      • University of California San Diego
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Merit Health Wesley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• signed informed consent
• symptomatic infrainguinal lower extremity vascular disease (Rutherford category 3, 4, 5 or 6), stable for at least 2 weeks prior to study inclusion
• lesions in the superficial femoral artery (SFA), popliteal, or infrapopliteal arteries at least one angiographically identifiable infrageniculate artery
• patients must be poor surgical candidates, indicated by at least one of the following conditions:
• absence of venous autologous grafts (that is, lack of a suitable vein to use for bypass)
• poor (diffusely diseased or <=1mm diameter) or no distal vessels available for graft anastamosis
• high risk of surgical mortality, evidenced by American Society of Anesthesiologists Physical Class 4 or higher

Exclusion Criteria:

• age below 18 years
• pregnancy, or plan to become pregnant
• participation in another cardiovascular or peripheral vascular study
• myocardial infarction (MI) in prior month
• stents at treatment site
• disorders or allergies precluding use of radiographic contrast
• renal insufficiency sever enough to contraindicate use of radiographic contrast
• contraindication to treatment with anticoagulants
• untreated ipsilateral iliac stenosis >70%
• inability or unwillingness of the patient to comply with intended examinations
• unavailability of required procedural or imaging equipment
• lesion located in a graft
• hemodynamically significant arrhythmia or left ventricular ejection fraction <20%
• life expectancy less than 6 months
• necrosis necessitating major amputation
• unwillingness of the patient to be anti-coagulated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RA-308 Excimer Laser and DABRA Catheter; Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions that cannot be crossed with standard guidewires. The catheter and laser are a system, and cannot be used separately.	Device: RA-308 Excimer Laser and DABRA Catheter; See information already included in arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crossing the Target Lesion	Crossing the target lesion based on angiographic analysis	at time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With no Device-related Major Adverse Events	Number of participants with no device-related major adverse events as determined by physician evaluation	at time of procedure, up to an hour
Number of Participants With Target Lesion Revascularization	Number of participants with target lesion revascularization as determined by physician evaluation	30 days
Number of Participants With Target Lesion Revascularization	Number of participants with target lesion revascularization as determined by physician evaluation	6 months

Collaborators and Investigators

• Sponsor: Ra Medical Systems
• Investigators: Principal Investigator: Ehtisham Mahmud, UCSD

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2016
• Primary Completion (Actual): May 3, 2017
• Study Completion (Actual): July 14, 2017

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 11, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: October 23, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: chronic total occlusion; excimer laser; percutaneous catheter; photoablation; symptomatic infrainguinal lower extremity vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: RMS-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes