Atherectomy By Laser Ablation With Turbo-Elite

Spectranetics Corporation44 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Peripheral Vascular Disease

Interventions

Turbo-Elite Laser CatheterDEVICE

Application of laser energy to remove blockage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 30 day follow-up

Secondary Outcomes

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.

Time frame: Day 1

Characterization of Adjunctive Therapy Use

Adjunctive therapy use will be characterized by frequencies.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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