Comparison of the PrimAry Long Versus Short Coverage With... | NCT02701881

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

NCT02701881

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Feb 15, 2019Actual

Enrollment

220Estimated

Phase

Phase 4

Conditions

Femoropopliteal Artery Disease

Interventions

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

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Aug 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Feb 29, 2016

First Submission Date that Met QC Criteria

Mar 7, 2016

First Posted Date

Mar 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2019

Last Update Posted Date

Feb 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

220Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary patency rate	Absence of restenosis >50%	12 months

Secondary Outcomes

Measure	Description	Time Frame
Target vessel revascularization rate	repeat intervention or surgical treatment due to loss of patency at the target vessel	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Division of Cardiology, Department of Internal Medicine, Severance Hospital	Recruiting	Seoul		120-752	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36337904	Derived	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.