Atherectomy By Laser Ablation With Turbo-Elite

Study Overview
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Brief Summary
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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%.

Official Title
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Atherectomy By Laser Ablation With Turbo-Elite

Conditions
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Peripheral Arterial Disease, Peripheral Vascular Disease

Intervention / Treatment
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* Device: Turbo-Elite Laser Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Turbo-Elite Atherectomy<br> | Device: Turbo-Elite Laser Catheter<br>* Application of laser energy to remove blockage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis | 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. | Day 1 | 
| Primary Safety Endpoint is Freedom From Major Adverse Event (MAE) | 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. | 30 day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final Procedure Residual Stenosis After All Therapy | A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure. | Day 1 | 
| Characterization of Adjunctive Therapy Use | Adjunctive therapy use will be characterized by frequencies. | Day 1 | 
| Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. | 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. | Baseline and 30 Days post-procedure | 
| Rutherford Class (RCC) Change | 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. | Baseline and 30 days of procedure | 
| Freedom From Target Lesion Revascularization (TLR) Through 180 Days. | Freedom from target lesion revascularization (TLR) through 180 days post procedure | Day 180 (6 Months) |