NCT02701881

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Femoropopliteal Artery Disease

Interventions

Type	Name	Description
DEVICE	Long stenting using drug-eluting stent (Zilver PTX)	Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty
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

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2016-03-08
• Last updated: 2019-02-15

Locations

1 site across 1 country: South Korea