Femoropopliteal Artery DiseasePhase 4NCT02701881
Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study
A Phase 4 study testing Long stenting using drug-eluting stent (Zilver PTX) and Spot stenting using drug-eluting stent (Zilver PTX) in people with Femoropopliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Femoropopliteal Artery Disease
- What is being tested?
- Long stenting using drug-eluting stent (Zilver PTX) and Spot stenting using drug-eluting stent (Zilver PTX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Aug 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- Popliteal artery stenosis >50% at P2 or P3 segment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, 120-752
Dong-Hoon Choi, MD, 82 2 2228 8449, cdhlyj@yuhs.ac
About this study
- 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
- Being tested
- Long stenting using drug-eluting stent (Zilver PTX), Spot stenting using drug-eluting stent (Zilver PTX)
- Keywords
- Femoropopliteal Artery, Drug-eluting Stent, Endovascular Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long stenting using drug-eluting stent (Zilver PTX)Device
Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty
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
| Study group | Role | What they receive |
|---|---|---|
| Long stenting group | Experimental | Not described Receives: Device: Long stenting using drug-eluting stent (Zilver PTX) |
| Short stenting group | Active comparator | Not described Receives: Device: Spot stenting using drug-eluting stent (Zilver PTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency rate
Absence of restenosis >50%
Measured: 12 months
Secondary outcomes (1)
Target vessel revascularization rate
repeat intervention or surgical treatment due to loss of patency at the target vessel
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Femoropopliteal Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701881
- Sponsor's protocol ID
- 1-2014-0072
- Status last verified
- Feb 2019
- First submitted
- 29 Feb 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36337904
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study
- ClinicalTrials.gov ID
- NCT02701881
- Acronym / sponsor ID
- 1-2014-0072
- Conditions
- Femoropopliteal Artery Disease
- Keywords
- Femoropopliteal Artery, Drug-eluting Stent, Endovascular Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Clinical criteria:
- Anatomical criteria:
Key exclusion criteria (16 listed)
- A. Clinical criteria
- Angiographic criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long stenting using drug-eluting stent (Zilver PTX)Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty | Device | Long stenting group |
| 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 | Device | Short stenting group |
Primary outcome
Primary patency rate
Time frame: 12 months
Absence of restenosis >50%
1 secondary outcome
Target vessel revascularization rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 36337904Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Division of Cardiology, Department of Internal Medicine, Severance Hospital
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Long stenting using drug-eluting stent (Zilver PTX) and Spot stenting using drug-eluting stent (Zilver PTX) in people with Femoropopliteal Artery Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.