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

Phase 4

• Conditions: Femoropopliteal Artery Disease
• Interventions: Device: Long stenting using drug-eluting stent (Zilver PTX); Device: Spot stenting using drug-eluting stent (Zilver PTX)

• Registration Number: NCT02701881
• Lead Sponsor: Yonsei University

Brief Summary

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Long stenting group	Long stenting using drug-eluting stent (Zilver PTX)	-
Short stenting group	Spot stenting using drug-eluting stent (Zilver PTX)	-

Primary Outcome Measures

Name	Time	Method
Primary patency rate	12 months	Absence of restenosis \>50%

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization rate	12 months	repeat intervention or surgical treatment due to loss of patency at the target vessel

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of