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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis

A legfontosabb adatok

Ki végzi
Chunshui He
Hol
Kína10 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toborzás még nem indult
Résztvevők
600 fő, tervezett
Kezdés
2027. jan. 1.
Várható befejezés
2030. dec. 31.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A vizsgált kezelések
  • Drug-Coated Balloon-First Strategy
  • Eluvia Drug-Eluting Stent-First Strategy
A regiszteradat frissítve
2026. november 2.

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 5 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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

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A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • 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.

    Kezelés: 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.

    Kezelés: Eluvia Drug-Eluting Stent-First Strategy

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Title: Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis: A Prospective, Multicenter, Cohort Study (The Defier Study)
A regiszteradat frissítve
2026. november 2.