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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Femoropopliteal Artery Disease

Treatments: Device: Long stenting using drug-eluting stent (Zilver PTX); Device: Spot stenting using drug-eluting stent (Zilver PTX)

Study type: Interventional

Funder types: Other

Identifiers

NCT02701881

1-2014-0072

Details and patient eligibility

About

• 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Long stenting group

Experimental group

Treatment:

Device: Long stenting using drug-eluting stent (Zilver PTX)

Short stenting group

Active Comparator group

Treatment:

Device: Spot stenting using drug-eluting stent (Zilver PTX)