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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Homogenous Lesions |
| ||
| Heterogenous Lesions |
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| Calcific Lesions |
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| Restenotic Lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser Atherectomy | Device | The Turbo-Power is laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA). |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of stenosis | 1. Final reduction of stenosis post procedure, determined by angiogram and intravascular ultrasound (IVUS). | immediately post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients with homogenous, heterogeneous, calcific, or restenotic with above the knee lesions eligible for treatment with laser atherectomy with Turbo-Power (target will be 15 patients enrolled in each category by lesions morphology).
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| Name | Affiliation | Role |
|---|---|---|
| George Adams, MD | UNC Hospitals - REX | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rex Hospital | Raleigh | North Carolina | 27607 | United States |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |