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Atherectomy By Laser Ablation With Turbo-Elite (ABLATE)

Primary Purpose

Peripheral Arterial Disease, Peripheral Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Turbo-Elite Laser Catheter
Sponsored by
Spectranetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Turbo-Elite Atherectomy

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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.
    Characterization of Adjunctive Therapy Use
    Adjunctive therapy use will be characterized by frequencies.
    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.
    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.
    Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
    Freedom from target lesion revascularization (TLR) through 180 days post procedure

    Full Information

    First Posted
    November 26, 2014
    Last Updated
    August 2, 2021
    Sponsor
    Spectranetics Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02307370
    Brief Title
    Atherectomy By Laser Ablation With Turbo-Elite
    Acronym
    ABLATE
    Official Title
    Atherectomy By Laser Ablation With Turbo-Elite
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (Actual)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Spectranetics Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes

    5. Study Description

    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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Arterial Disease, Peripheral Vascular Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Turbo-Elite Atherectomy
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Turbo-Elite Laser Catheter
    Intervention Description
    Application of laser energy to remove blockage
    Primary Outcome Measure Information:
    Title
    Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis
    Description
    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
    Title
    Primary Safety Endpoint is Freedom From Major Adverse Event (MAE)
    Description
    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 Outcome Measure Information:
    Title
    Final Procedure Residual Stenosis After All Therapy
    Description
    A Final Procedure Residual Stenosis by visual assessment after all therapy will be accessed acutely during the procedure.
    Time Frame
    Day 1
    Title
    Characterization of Adjunctive Therapy Use
    Description
    Adjunctive therapy use will be characterized by frequencies.
    Time Frame
    Day 1
    Title
    Ankle-Brachial Index (ABI) Change From Baseline to 30 Days.
    Description
    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
    Title
    Rutherford Class (RCC) Change
    Description
    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.
    Time Frame
    Baseline and 30 days of procedure
    Title
    Freedom From Target Lesion Revascularization (TLR) Through 180 Days.
    Description
    Freedom from target lesion revascularization (TLR) through 180 days post procedure
    Time Frame
    Day 180 (6 Months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

    Atherectomy By Laser Ablation With Turbo-Elite

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