Atherectomy By Laser Ablation With Turbo-Elite

Not Applicable

Completed

Brief Summary: The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.

Recruitment & Eligibility

Inclusion Criteria

PAD with Rutherford Class 1-4
Patient is able to walk unassisted or with non-motorized assistive devices.
Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
Documented stenosis by duplex ≥50%

Exclusion Criteria

Patient is pregnant or breast feeding.
Evidence of Acute Limb Ischemia within 7 days prior to procedure.
CVA < 60 days prior to procedure.
MI < 60 days prior to procedure.
Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
Previously identified severe calcium in the vessel.

Arm && Interventions

Group	Intervention	Description
Turbo-Elite Atherectomy	Turbo-Elite Laser Catheter	-

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis	Day 1	The primary efficacy endpoint target was a mean reduction in percent stenosis of greater than 20% in each study participating at the time of the procedure by Angiographic Core Lab assessment after Turbo-Elite use. A participant showing a mean reduction of 20% was considered a success for the primary efficacy endpoint.
Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)	30 day follow-up	The primary safety endpoint target was 80% of study participant with freedom from a Major Adverse Event (MAE) through 30 day follow-up. A MAE was defined as: all cause death, major amputation in the target limb, or target lesion revascularization.

Secondary Outcome Measures

Name	Time	Method
Freedom From Target Lesion Revascularization (TLR) Through 180 Days.	Day 180 (6 Months)	Freedom from target lesion revascularization (TLR) through 180 days post procedure
Final Procedure Residual Stenosis After All Therapy	Day 1	A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.
Rutherford Class (RCC) Change	Baseline and 30 days of procedure	Rutherford Class (RCC) will be assessed at baseline and within 30 days of the procedure. The Rutherford-Becker Clinical Categories (RCC) are a classification system of chronic limb ischemia ranging from 0 (asymptomatic; no hemodynamically significant occlusive disease) to 6 (major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable). Lower categories represent better clinical status.
Characterization of Adjunctive Therapy Use	Day 1	Adjunctive therapy use will be characterized by frequencies.
Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.	Baseline and 30 Days post-procedure	ABI will be assessed at baseline and within 30 days of the procedure. The ABI is calculated ratio of the highest ankle blood pressure to the highest arm blood pressure. The ABI is a non-invasive tool for screening for Peripheral Artery Disease.