Atherectomy By Laser Ablation With Turbo-Elite (ABLATE)

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 Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease
• Intervention / Treatment: Device: Turbo-Elite Laser Catheter

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Turbo-Elite Atherectomy	Device: Turbo-Elite Laser Catheter; Application of laser energy to remove blockage

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Spectranetics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): August 27, 2021
• Last Update Submitted That Met QC Criteria: August 2, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: D024204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes