Femoropopliteal In-Stent Restenosis (ISR)NCT07277218
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
An observational study of Femoropopliteal In-Stent Restenosis (ISR), run by Chunshui He.
Trial summary
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment. Drug-coated balloons (DCBs) avoid an additional permanent metallic layer, whereas drug-eluting stents provide mechanical scaffolding with local… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoropopliteal In-Stent Restenosis (ISR)
- What is being tested?
- Drug-Coated Balloon-First Strategy and Eluvia Drug-Eluting Stent-First Strategy
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2029
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with symptomatic Rutherford category 2-5 femoropopliteal in-stent restenosis undergoing clinically indicated endovascular treatment at participating tertiary vascular centers in China. Potentially eligible patients will be screened consecutively. Treatment is selected by the treating physician as part of routine clinical care and is not assigned by the research protocol. The primary comparative cohort includes patients for whom both DCB-first and Eluvia-first strategies remain clinically feasible after lesion preparation.
Who may be able to join
- Age >18 years. Willing and able to provide written informed consent. Rutherford Clinical Category 2-5. Angiographically confirmed ≥50% stenosis or occlusion within a previously implanted superficial femoral or proximal popliteal artery stent more than 30 days after implantation.
- The target lesion is within the previously stented segment or extends no more than 3 cm proximally or distally beyond the prior stent.
- Total target lesion length ≤30 cm. At least one patent below-the-knee runoff vessel. Willing and able to complete follow-up through 24 months. After lesion preparation, both the DCB-first and Eluvia-first strategies remain clinically feasible.
Who cannot join
- Pregnancy or lactation. Rutherford Clinical Category 0 or 6. Target lesion stenosis <50%. Target lesion length >30 cm. Severe calcification precluding endovascular treatment. Acute limb ischemia or acute thrombosis of the target limb. Untreated hemodynamically significant aorto-iliac inflow disease. Cerebrovascular accident within 60 days before the index procedure. Contraindication to required antiplatelet or anticoagulant therapy. Inability or unwillingness to provide informed consent. Life expectancy <2 years or another factor making completion of follow-up unlikely.
- Persistent post-preparation anatomy that mandates one treatment strategy and therefore eliminates clinical equipoise.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
chunshui he, MD contact
About this study
Official title: Title: Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis: A Prospective, Multicenter, Cohort Study (The Defier Study)
Femoropopliteal in-stent restenosis (ISR) remains an important cause of recurrent symptoms and repeat revascularization after lower-extremity endovascular treatment. Drug-coated balloons (DCBs) avoid an additional permanent metallic layer, whereas drug-eluting stents provide mechanical scaffolding with local antiproliferative drug delivery. Direct prospective comparative-effectiveness evidence in symptomatic femoropopliteal ISR remains limited.
DEFIER is a prospective, multicenter observational comparative-effectiveness cohort study enrolling up to 600 adults with symptomatic Rutherford category 2-5 femoropopliteal ISR. Treatment is selected by the treating physician as part of routine clinical care and is not assigned by the research protocol. After guidewire crossing and lesion preparation, patients for whom both strategies remain clinically feasible enter the primary comparative cohort. The DCB-first strategy uses IN.PACT Admiral or AcoArt Orchid 0.035, with protocol-defined focal bare-metal bailout stenting permitted when clinically required. The Eluvia-first strategy uses the Eluvia drug-eluting vascular stent.
Participants will be followed for 24 months. The primary outcome is the cumulative incidence of first clinically driven target lesion revascularization (CD-TLR) through 24 months. Comparative analyses will use a prespecified target-trial framework and propensity-score overlap weighting, with death and major target-limb amputation treated as competing events.
- Being tested
- Drug-Coated Balloon-First Strategy, Eluvia Drug-Eluting Stent-First Strategy
- Keywords
- in-stent restenosis ; femoropopliteal artery; drug-coated balloon ; drug-eluting stent; peripheral arterial disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated Balloon-First StrategyDevice
Physician-selected routine-care treatment with either IN.PACT Admiral or AcoArt Orchid 0.035 after lesion preparation. Device size and length are selected according to vessel anatomy and locally approved instructions for use. Protocol-defined focal bare-metal bailout stenting is permitted when clinically required for a suboptimal DCB result.
Eluvia Drug-Eluting Stent-First StrategyDevice
Physician-selected routine-care treatment with the Eluvia Drug-Eluting Vascular Stent System after lesion preparation. Stent diameter and length are selected according to vessel anatomy and locally approved instructions for use.
| Study group | Role | What they receive |
|---|---|---|
| DCB-First Strategy Cohort | Participants whose treating physician selects a drug-coated balloon-first strategy as part of routine clinical care after lesion preparation and confirmation that both treatment strategies remain clinically feasible. The prespecified DCB platforms are IN.PACT Admiral and AcoArt Orchid 0.035. Protocol-defined focal bare-metal bailout stenting is permitted when clinically necessary. Treatment is not assigned by the research protocol. Receives: Device: Drug-Coated Balloon-First Strategy | |
| Eluvia-First Strategy Cohort | Participants whose treating physician selects an Eluvia-first strategy as part of routine clinical care after lesion preparation and confirmation that both treatment strategies remain clinically feasible. The strategy uses the Eluvia Drug-Eluting Vascular Stent System. Treatment is not assigned by the research protocol. Receives: Device: Eluvia Drug-Eluting Stent-First Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically-Driven Target Lesion Revascularization (CD-TLR)
Clinically driven target lesion revascularization (CD-TLR) is defined as repeat percutaneous or surgical revascularization of the target lesion, defined as the treated segment plus 5 mm proximally and distally, for ≥50% restenosis or occlusion accompanied by recurrent or worsening limb symptoms, Rutherford-category deterioration, ABI/TBI decline consistent with hemodynamic worsening, including an ABI decline ≥0.15 from the post-procedure reference when applicable, or failure or worsening of tissue loss in patients with chronic limb-threatening ischemia. Events will be independently adjudicated.
Measured: 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal In-Stent Restenosis (ISR)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunshui He
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Department of Vascular Surgery, Qingdao Haici Hospital Affiliated to Qingdao University, Qingdao, China., Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China., Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China., Department of Vascular Surgery, Huashan Hospital, Fudan University, Shanghai, China., Department of Cardiovascular Surgery, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China., Biomedical Informatics and Statistics Center, School of Public Health.Fudan University, Shanghai, China., Department of Vascular Surgery, Xuanwu Hospital Capital MedicalUniversity, Beijing, China., Department of Vascular Surgery, School of Medicine, AffiliatedHangzhou First People's Hospital, Zhejiang University, Hangzhou, China.
- Responsible party
- Sponsor-investigator, Chunshui He, Chengdu University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277218
- Sponsor's protocol ID
- CZY FY XGWK2
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided