Clinical trial NCT02701881: Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Femoropopliteal Artery Disease
Keywords: Femoropopliteal Artery
Drug-eluting Stent
Endovascular Therapy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 220
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary patency rate
timeFrame: 12 months
Secondary outcomes:
measure: Target vessel revascularization rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Severance Hospital
Study officials:
References:
citation: Park JI, Ko YG, Lee YJ, Lee SJ, Hong SJ, Ahn CM, Kim JS, Kim BK, Hong MK, Yu CW, Rha SW, Park JK, Min PK, Yoon CH, Lee SR, Park SH, Choi DH. Long coverage with drug-eluting stents is superior to spot coverage for long femoropopliteal artery disease: PARADE II study. Front Cardiovasc Med. 2022 Oct 19;9:1022071. doi: 10.3389/fcvm.2022.1022071. eCollection 2022.