MedTrace Logo

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

NCT02701881 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-02-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701881 on ClinicalTrials.gov