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The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pathway PV Atherectomy System
Sponsored by
Pathway Medical Technologies Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Documented symptomatic atherosclerotic peripheral vascular disease
  • Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries
  • The patient has been informed of the nature of the study and has provided informed consent
  • The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits

Exclusion Criteria:

  • Target lesion is located in the iliac artery.
  • Target lesion stenosis is < 70%.
  • Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
  • Patient is unable to participate for the duration of the study.
  • Patient is currently participating or has participated in a study with another investigational medical device or medication.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Major Adverse Events (MAEs) Within 30 Days
    Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.

    Secondary Outcome Measures

    Average Rutherford Classification Score at 6 Months
    Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)
    Average Ankle Brachial Index (ABI) at 6 Months
    Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)
    Freedom From Target Lesion Revascularization (TLR) at 6 Months
    Number of patients that did not require target lesion revascularization 6 months after index procedure.

    Full Information

    First Posted
    May 8, 2008
    Last Updated
    May 18, 2009
    Sponsor
    Pathway Medical Technologies Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00676494
    Brief Title
    The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions
    Official Title
    A Prospective, Single Arm, Multi-Center Study to Assess Performance of the Pathway PV Atherectomy System During Percutaneous Peripheral Vascular (PV) Interventions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2006 (undefined)
    Primary Completion Date
    July 2007 (Actual)
    Study Completion Date
    February 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pathway Medical Technologies Inc.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in peripheral vasculature. This is a prospective, single arm, multi-center study to obtain safety and performance data for the Pathway PV Atherectomy System when used as a primary or adjunctive therapy for percutaneous intervention to remove atherosclerotic disease, debris, and thrombus from the lower limb peripheral vasculature.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    172 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Pathway PV Atherectomy System
    Intervention Description
    The Pathway PV Atherectomy System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic debris and thrombus in lower limb peripheral vasculature during percutaneous interventional procedures.
    Primary Outcome Measure Information:
    Title
    Major Adverse Events (MAEs) Within 30 Days
    Description
    Major adverse events (MAEs) are any death, target vessel revascularization (TVR), target lesion revascularization (TLR), myocardial infarction (MI), or amputation of the treated limb that occurred within 30 days of the index procedure.
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Average Rutherford Classification Score at 6 Months
    Description
    Rutherford Classification measures lower limb peripheral arterial disease (PAD) by evaluating and rating symptoms. Score: 0 (no symptoms or discomfort in leg) to 6 (Tissue loss or gangrene in leg)
    Time Frame
    6 months
    Title
    Average Ankle Brachial Index (ABI) at 6 Months
    Description
    Ankle Brachial Index (ABI) is the ratio of the blood pressure in the lower legs to the blood pressure in the arms. Compared to the arm, lower blood pressure in the leg is a symptom of peripheral artery disease (PAD). Range: Normal arteries (1.0 - 1.2) to Severe arterial disease (under 0.5)
    Time Frame
    6 months
    Title
    Freedom From Target Lesion Revascularization (TLR) at 6 Months
    Description
    Number of patients that did not require target lesion revascularization 6 months after index procedure.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Documented symptomatic atherosclerotic peripheral vascular disease Target lesion(s) is/are located in a superficial femoral, popliteal and/or infrapopliteal arteries The patient has been informed of the nature of the study and has provided informed consent The patient agrees and has capability to meet study requirements and be present at the follow-up clinic visits Exclusion Criteria: Target lesion is located in the iliac artery. Target lesion stenosis is < 70%. Interventional treatment is intended for in-stent restenosis at the peripheral vascular site. Patient is unable to participate for the duration of the study. Patient is currently participating or has participated in a study with another investigational medical device or medication.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Thomas Zeller, MD
    Organizational Affiliation
    Herz Zentrum Bad Krozingen, Germany
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Dierk Scheinert, MD
    Organizational Affiliation
    University of Leipzig
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19995118
    Citation
    Zeller T, Krankenberg H, Steinkamp H, Rastan A, Sixt S, Schmidt A, Sievert H, Minar E, Bosiers M, Peeters P, Balzer JO, Gray W, Tubler T, Wissgott C, Schwarzwalder U, Scheinert D. One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial. J Endovasc Ther. 2009 Dec;16(6):653-62. doi: 10.1583/09-2826.1.
    Results Reference
    derived

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    The Pathway PVD Study for Percutaneous Peripheral Vascular Interventions

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