Phase 3
N=252
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Peripheral Arterial Disease
Bottom Line
View on ClinicalTrials.gov: NCT01330628 ↗Enrolled (actual)
252
Serious AEs
68.7%
Results posted
Jun 2016
Primary outcome: Primary: Freedom From Target Lesion Revascularization (TLR) — 123; 43 # of participants free from TLR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Turbo Elite Laser and Turbo Tandem Laser Guide Catheters (Device); Balloon angioplasty (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spectranetics Corporation
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Target Lesion Revascularization (TLR) |
123; 43 | — |
| PRIMARY Freedom From Major Adverse Events (MAE) |
158; 61 | — |
Summary
The purpose of the study is to evaluate the safety and efficacy of laser atherectomy with balloon angioplasty compared to balloon angioplasty alone in the treatment of above the knee peripheral artery in-stent restenosis.
Eligibility Criteria
Inclusion Criteria
- PAD with Rutherford class 1-4
- Resting ABI =50%)
- Target lesion length >=4 cm; no more than 3 cm outside stent at either end
- Vessel diameter >=5 mm and = 2.5 mg/dl unless dialysis dependent
- Previous treatment to target vessel within 3 months of study procedure
- Drug eluting stents or covered stents in target lesion
- Ipsilateral and/or contralateral iliac stenosis >= 50% DS that is not successfully treated prior to index procedure or with final residual stenosis 50% that will require preplanned or predicted treatment within 30 days(prior to the 6 month follow up)
- Tibial artery containing a >50% Diameter Stenosis (DS) by visual estimate after popliteal
- Grade 4 or 5 stent fracture affecting target stent or proximal to the target stent, or where evidence of stent protrusion into the lumen is noted on angiography in 2 orthogonal views.
Data sourced from ClinicalTrials.gov (NCT01330628). 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.