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

Femoropopliteal Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701881
• Other study ID #: 1-2014-0072
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: August 2021

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoropopliteal Artery Disease

Intervention

Device:
• Long stenting using drug-eluting stent (Zilver PTX)
Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty
• 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

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology, Department of Internal Medicine, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency rate	Absence of restenosis >50%	12 months
Secondary	Target vessel revascularization rate	repeat intervention or surgical treatment due to loss of patency at the target vessel	12 months