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Completed

NCT Number: NCT02307370

Atherectomy By Laser Ablation With Turbo-Elite

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%.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Turbo-Elite Laser Catheter

Device

Application of laser energy to remove blockage

Primary outcomes

  1. Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis

    Time frame: 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.

  2. Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)

    Time frame: 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 outcomes

  1. Final Procedure Residual Stenosis After All Therapy

    Time frame: Day 1

    A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.

  2. Characterization of Adjunctive Therapy Use

    Time frame: Day 1

    Adjunctive therapy use will be characterized by frequencies.

  3. Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.

    Time frame: 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.

  4. Rutherford Class (RCC) Change

    Time frame: 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.

  5. Freedom From Target Lesion Revascularization (TLR) Through 180 Days.

    Time frame: Day 180 (6 Months)

    Freedom from target lesion revascularization (TLR) through 180 days post procedure

Sponsors and collaborators

Lead sponsor

Spectranetics Corporation

Industry

Registry information

Acronym: ABLATE

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 4, 2014
Registry last updated
Aug 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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