NCT02701881

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

5.6 years

First QC Date

February 29, 2016

Last Update Submit

February 12, 2019

Conditions

Femoropopliteal Artery Disease

Keywords

Femoropopliteal ArteryDrug-eluting StentEndovascular Therapy

Outcome Measures

Primary Outcomes (1)

  • Primary patency rate

    Absence of restenosis \>50%

    12 months

Secondary Outcomes (1)

  • Target vessel revascularization rate

    12 months

Study Arms (2)

Long stenting group

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

Short stenting group

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

Interventions

Long stenting using drug-eluting stent (Zilver PTX)DEVICE

Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty

Long stenting group
Spot stenting using drug-eluting stent (Zilver PTX)DEVICE

Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion

Short stenting group

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical criteria:
  • Age 19 years of older
  • Symptomatic peripheral artery disease:
  • Moderate or severe claudication (Rutherford category 2 or 3)
  • Critical limb ischemia (Rutherford category 4 or 5)
  • Patients with signed informed consent
  • Anatomical criteria:
  • Target lesion length ≥150 mm by angiographic estimation
  • Stenosis of more than 50% in femoropopliteal artery
  • At least one patent (less than 50 percent stenosed) tibioperoneal runoff vessel.

You may not qualify if:

  • A. Clinical criteria
  • Acute critical limb ischemia
  • Severe critical limb ischemia (Rutherford category 6)
  • Major bleeding history within prior 2 months
  • Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel or contrast agents
  • Age \> 85 years
  • Severe hepatic dysfunction (\> 3 times normal reference values)
  • Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl
  • Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
  • LVEF(left ventricular ejection fraction) \<40% or clinically overt congestive heart failure
  • Pregnant women or women with potential childbearing
  • Life expectancy \<1 year due to comorbidity
  • Angiographic criteria
  • Previous bypass surgery or stenting of the superficial femoral artery
  • Untreated inflow disease of the ipsilateral pelvic arteries (more than 50%stenosis or or occlusion
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Department of Internal Medicine, Severance Hospital

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36337904DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 8, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

February 15, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)