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Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions
Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
Sponsored by
Skane University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vascular Diseases

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Critical limb ischemia RC 4-6

Lesions in superficial femoral artery and popliteal artery (p1 -p2)

Target vessel 4-8mm

At least I 1 vessel runoff to the foot

Age >18 years

Exclusion Criteria:

Pregnancy

Patient disapproval

Age <18 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Drug Eluting Stent (DES)

    Bare Metal Stent (BMS)

    Arm Description

    Drug Eluting Stent (DES). Zilver PTX.

    Bare Metal Stent (BMS). Zilver Flex

    Outcomes

    Primary Outcome Measures

    Freedom from TLR (Target Lesion Revascularization)
    Fraction of study subjects without need for retreatment at treatment location
    Freedom from TLR (Target Lesion Revascularization)
    Fraction of study subjects without need for retreatment at treatment location
    Freedom from TLR (Target Lesion Revascularization)
    Fraction of study subjects without need for retreatment at treatment location
    Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
    Functioning revascularization without adjunctive measures
    Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
    Functioning revascularization without adjunctive measures
    Event Free Survival
    Alive without vascular events

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2022
    Last Updated
    August 5, 2023
    Sponsor
    Skane University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05296031
    Brief Title
    Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
    Official Title
    Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2013 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    August 31, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Skane University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    49 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Drug Eluting Stent (DES)
    Arm Type
    Active Comparator
    Arm Description
    Drug Eluting Stent (DES). Zilver PTX.
    Arm Title
    Bare Metal Stent (BMS)
    Arm Type
    Placebo Comparator
    Arm Description
    Bare Metal Stent (BMS). Zilver Flex
    Intervention Type
    Device
    Intervention Name(s)
    Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions
    Intervention Description
    Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
    Intervention Type
    Device
    Intervention Name(s)
    Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
    Intervention Description
    Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
    Primary Outcome Measure Information:
    Title
    Freedom from TLR (Target Lesion Revascularization)
    Description
    Fraction of study subjects without need for retreatment at treatment location
    Time Frame
    6 months
    Title
    Freedom from TLR (Target Lesion Revascularization)
    Description
    Fraction of study subjects without need for retreatment at treatment location
    Time Frame
    12 months
    Title
    Freedom from TLR (Target Lesion Revascularization)
    Description
    Fraction of study subjects without need for retreatment at treatment location
    Time Frame
    24 months
    Title
    Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
    Description
    Functioning revascularization without adjunctive measures
    Time Frame
    12months
    Title
    Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
    Description
    Functioning revascularization without adjunctive measures
    Time Frame
    24 months
    Title
    Event Free Survival
    Description
    Alive without vascular events
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Critical limb ischemia RC 4-6 Lesions in superficial femoral artery and popliteal artery (p1 -p2) Target vessel 4-8mm At least I 1 vessel runoff to the foot Age >18 years Exclusion Criteria: Pregnancy Patient disapproval Age <18 years

    12. IPD Sharing Statement

    Learn more about this trial

    Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex

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