Peripheral Arterial Disease Clinical Trial
Official title:
REX - A Pilot Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Purpose: To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with
a predetermined laser treatment protocol in patients presenting with varying lesion types or
morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous
(plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of
calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment)
associated with peripheral arterial disease (PAD).
Participants: 60 patients with PAD undergoing a revascularization procedure (treatment of a
narrowed blood vessel) involving above the knee (ATK) lesion(s) eligible for treatment with
laser atherectomy (a option for treatment of blocked blood vessels.)
Procedures (methods): Patients' qualifying lesions will be assessed with angiography (a test
that uses a special dye and camera to take pictures of the blood flow in an artery) and
intravascular ultrasound (IVUS) and categorized (homogenous, heterogeneous, calcific or
restenotic) and determined to be treatable with laser atherectomy per standard of care.
Qualified patients will undergo standard of care treatment with the Spectranetics Turbo-Power
laser catheter for three passes with increasing settings 'low' (40/60), 'medium' (50/40) and
'high'(60/60), respectively. After each pass, assessments of lumen quality and residual
stenosis (narrowing still present after treatment) will be determined by angiogram and IVUS.
The operator may finish the procedure per standard of care/investigator discretion after the
protocol defined laser passes are completed.
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