Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study

February 12, 2019 updated by: Yonsei University
  • Prospective, randomized, controlled, multi-center study
  • A total of 220 subjects with long femoropopliteal lesions will be included according to inclusion and exclusion criteria.
  • Patients will be randomized in a 1:1 manner into long stenting group versus short stenting group. and treated with Zilver PTX for long femoropopliteal lesions
  • Patients will be followed clinically for 1 year after the procedure.
  • Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Division of Cardiology, Department of Internal Medicine, Severance Hospital
        • Contact:
          • Dong-Hoon Choi, MD
          • Phone Number: 82 2 2228 8449
          • Email: cdhlyj@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical criteria:

    1. Age 19 years of older

    2. Symptomatic peripheral artery disease:

      1. Moderate or severe claudication (Rutherford category 2 or 3)
      2. Critical limb ischemia (Rutherford category 4 or 5)
    3. Patients with signed informed consent

  • Anatomical criteria:

    1. Target lesion length ≥150 mm by angiographic estimation
    2. Stenosis of more than 50% in femoropopliteal artery
    3. At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

Exclusion Criteria:

  • A. Clinical criteria

    1. Acute critical limb ischemia
    2. Severe critical limb ischemia (Rutherford category 6)
    3. Major bleeding history within prior 2 months
    4. Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
    5. Age > 85 years
    6. Severe hepatic dysfunction (> 3 times normal reference values)
    7. Significant renal dysfunction (Serum creatinine > 2.0 mg/dl
    8. Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
    9. LVEF(left ventricular ejection fraction) <40% or clinically overt congestive heart failure
    10. Pregnant women or women with potential childbearing
    11. Life expectancy <1 year due to comorbidity

  • Angiographic criteria

    1. Previous bypass surgery or stenting of the superficial femoral artery
    2. Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion
    3. Popliteal artery stenosis >50% at P2 or P3 segment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long stenting group
Device: Long stenting using drug-eluting stent (Zilver PTX)
Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty
Active Comparator: Short stenting group
Device: Spot stenting using drug-eluting stent (Zilver PTX)
Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency rate
Time Frame: 12 months
Absence of restenosis >50%
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel revascularization rate
Time Frame: 12 months
repeat intervention or surgical treatment due to loss of patency at the target vessel
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 8, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1-2014-0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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