Femoropopliteal In-Stent Restenosis (ISR)
Conditions
Keywords
in-stent restenosis ; femoropopliteal artery; drug-coated balloon ; drug-eluting stent; peripheral arterial disease
Brief 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 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.
Interventions
DEVICEDrug-Coated Balloon-First Strategy
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.
DEVICEEluvia Drug-Eluting Stent-First Strategy
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.
Sponsors
Chunshui He
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.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically-Driven Target Lesion Revascularization (CD-TLR) | 24 months post-procedure | 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. |
Contacts
CONTACTchunshui he, MD
Outcome results
None listed