Phase 3
Completed N=252
Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis
Source: ClinicalTrials.gov NCT01330628 ↗Enrolled (actual)
252
Serious AEs
68.7%
Results posted
Jun 2016
Primary outcomePrimary: Freedom From Target Lesion Revascularization (TLR) — 123; 43 # of participants free from TLR
◆ Published Evidence
Highly cited
213citations · ~19 / year
Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).
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.
Linked Publications
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Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Target Lesion Revascularization (TLR) |
123; 43 | — |
| PRIMARY Freedom From Major Adverse Events (MAE) |
158; 61 | — |
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) and the linked publication. 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. Informational only — not medical advice.