Peripheral Arterial Disease
Conditions
Keywords
excimer laser, percutaneous catheter, photoablation, chronic total occlusion, symptomatic infrainguinal lower extremity vascular disease
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.
Interventions
DEVICERA-308 Excimer Laser and DABRA Catheter
See information already included in arm description
Sponsors
Ra Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crossing the Target Lesion | at time of procedure | Crossing the target lesion based on angiographic analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With no Device-related Major Adverse Events | at time of procedure, up to an hour | Number of participants with no device-related major adverse events as determined by physician evaluation |
| Number of Participants With Target Lesion Revascularization | 30 days | Number of participants with target lesion revascularization as determined by physician evaluation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RA-308 Excimer Laser and DABRA Catheter Treatment with the RA-308 excimer laser and DABRA catheter to treat chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease. The catheter and laser are a system, and cannot be used separately.
RA-308 Excimer Laser and DABRA Catheter: See information already included in arm description | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | RA-308 Excimer Laser and DABRA Catheter |
|---|---|
| Age, Continuous | 72 years |
| Chronic total occlusion | 64 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 64 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Mexico | 15 participants |
| Region of Enrollment United States | 49 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 64 |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 0 / 64 |
Outcome results
Primary
Crossing the Target Lesion
Crossing the target lesion based on angiographic analysis
Time frame: at time of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RA-308 Excimer Laser and DABRA Catheter | Crossing the Target Lesion | 60 Participants |
Secondary
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
Time frame: at time of procedure, up to an hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RA-308 Excimer Laser and DABRA Catheter | Number of Participants With no Device-related Major Adverse Events | 0 Participants |
Secondary
Number of Participants With Target Lesion Revascularization
Number of participants with target lesion revascularization as determined by physician evaluation
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RA-308 Excimer Laser and DABRA Catheter | Number of Participants With Target Lesion Revascularization | 0 Participants |
Secondary
Number of Participants With Target Lesion Revascularization
Number of participants with target lesion revascularization as determined by physician evaluation
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RA-308 Excimer Laser and DABRA Catheter | Number of Participants With Target Lesion Revascularization | 0 Participants |