search
Back to results

Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease (STRONG)

Primary Purpose

Peripheral Arterial Disease

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short spot stenting
Long lesion stenting
Sponsored by
Catharina Ziekenhuis Eindhoven
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:

  • PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
  • Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery
  • Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines
  • Unilateral occlusive disease
  • Age ≥ 18

Exclusion Criteria:

  • Patients with PAOD Rutherford category 5 and 6
  • Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat
  • Bilateral lesions with treatment indication
  • Contra-indication for anticoagulant therapy
  • Renal insufficiency (MDRD < 50 ml/min)
  • Life expectancy < 6 months
  • Known contrast allergy
  • Pregnancy
  • Unable to complete a questionnaire in the home language

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Short spot stenting

    Long lesion stenting

    Arm Description

    Short spot stenting

    Long lesion stenting

    Outcomes

    Primary Outcome Measures

    absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention

    Secondary Outcome Measures

    Full Information

    First Posted
    July 21, 2017
    Last Updated
    October 5, 2018
    Sponsor
    Catharina Ziekenhuis Eindhoven
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03227822
    Brief Title
    Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease
    Acronym
    STRONG
    Official Title
    Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    Unable to include the number of patients
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    February 1, 2015 (Actual)
    Study Completion Date
    February 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Catharina Ziekenhuis Eindhoven

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Short spot stenting
    Arm Type
    Experimental
    Arm Description
    Short spot stenting
    Arm Title
    Long lesion stenting
    Arm Type
    Experimental
    Arm Description
    Long lesion stenting
    Intervention Type
    Procedure
    Intervention Name(s)
    Short spot stenting
    Intervention Type
    Procedure
    Intervention Name(s)
    Long lesion stenting
    Primary Outcome Measure Information:
    Title
    absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4 Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines Unilateral occlusive disease Age ≥ 18 Exclusion Criteria: Patients with PAOD Rutherford category 5 and 6 Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat Bilateral lesions with treatment indication Contra-indication for anticoagulant therapy Renal insufficiency (MDRD < 50 ml/min) Life expectancy < 6 months Known contrast allergy Pregnancy Unable to complete a questionnaire in the home language

    12. IPD Sharing Statement

    Learn more about this trial

    Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease

    We'll reach out to this number within 24 hrs