N/A
N=64
Evaluating Plaque Photoablation Using an Excimer Laser in Patients With Lower Extremity Vascular Disease
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT02653456 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Crossing the Target Lesion — 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RA-308 Excimer Laser and DABRA Catheter (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ra Medical Systems
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crossing the Target Lesion |
60 | — |
| SECONDARY Number of Participants With no Device-related Major Adverse Events |
— | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
— | — |
| SECONDARY Number of Participants With Target Lesion Revascularization |
— | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT02653456). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.