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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RA-308 Excimer Laser and DABRA Catheter
Sponsored by
Ra Medical Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring excimer laser, percutaneous catheter, photoablation, chronic total occlusion, symptomatic infrainguinal lower extremity vascular disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • California Heart & Vascular Clinic
  • University of California San Diego
  • Merit Health Wesley

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RA-308 Excimer Laser and DABRA Catheter

Arm Description

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.

Outcomes

Primary Outcome Measures

Crossing the Target Lesion
Crossing the target lesion based on angiographic analysis

Secondary Outcome Measures

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
Number of Participants With Target Lesion Revascularization
Number of participants with target lesion revascularization as determined by physician evaluation
Number of Participants With Target Lesion Revascularization
Number of participants with target lesion revascularization as determined by physician evaluation

Full Information

First Posted
January 8, 2016
Last Updated
October 23, 2018
Sponsor
Ra Medical Systems
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1. Study Identification

Unique Protocol Identification Number
NCT02653456
Brief Title
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
Official Title
A Prospective, Multi Center Pilot Study Evaluating Plaque Photoablation Using the RA-308 Excimer Laser in Subjects With Symptomatic Infrainguinal Lower Extremity Vascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 7, 2016 (Actual)
Primary Completion Date
May 3, 2017 (Actual)
Study Completion Date
July 14, 2017 (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 Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
excimer laser, percutaneous catheter, photoablation, chronic total occlusion, symptomatic infrainguinal lower extremity vascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RA-308 Excimer Laser and DABRA Catheter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
RA-308 Excimer Laser and DABRA Catheter
Intervention Description
See information already included in arm description
Primary Outcome Measure Information:
Title
Crossing the Target Lesion
Description
Crossing the target lesion based on angiographic analysis
Time Frame
at time of procedure
Secondary Outcome Measure Information:
Title
Number of Participants With no Device-related Major Adverse Events
Description
Number of participants with no device-related major adverse events as determined by physician evaluation
Time Frame
at time of procedure, up to an hour
Title
Number of Participants With Target Lesion Revascularization
Description
Number of participants with target lesion revascularization as determined by physician evaluation
Time Frame
30 days
Title
Number of Participants With Target Lesion Revascularization
Description
Number of participants with target lesion revascularization as determined by physician evaluation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehtisham Mahmud
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Heart & Vascular Clinic
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Merit Health Wesley
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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