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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
application of laser energy to remove blockage followed by standard balloon angioplasty
standard balloon catheters for PTA
Freedom From Target Lesion Revascularization (TLR)
Number of participants free from Target Lesion Revascularization (TLR) through 6 months follow-up.
Time frame: 6 months
Freedom From Major Adverse Events (MAE)
Number of participants free from Major Adverse Events (MAE) at 30 days. MAE are defined all cause death, major amputation in the target limb, or target lesion revascularization (TLR) from procedure to 30 days (±7 days).
Time frame: 30 days
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St. Vincent's East
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Yale - New Haven Hospital
New Haven, Connecticut, United States
Washington Hospital Center
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...and 24 more locations