Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5

Обзор

The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.

Вмешательства

• Устройство Drug eluting stent (DES)
  DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
• Устройство Drug coated ballloon (DCB)
  DCB angioplasty with any commercially available drug-coated balloon

Первичные конечные точки

• Composite endpoint of major adverse cardiac event (MACE) [Срок оценки: 24 months of clinical follow-up after randomization]

Вторичные конечные точки (4)

• Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR [Срок оценки: 24 months of clinical follow-up after randomization]
• Individual endpoints of the composite endpoints [Срок оценки: 24 months of clinical follow-up after randomization]
• Stent thrombosis according to the ARC criteria [Срок оценки: 24 months of clinical follow-up after randomization]
• Safety endpoint: a composite endpoint of all-cause death and myocardial infarction [Срок оценки: 24 months of clinical follow-up after randomization]

Критерии участия

Критерии включения

• Patients with ischemic symptoms and/or evidence of myocardial ischemia
• Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
• Availability of an OCT-pullback of the target lesion
• Written informed consent by the patient for participation in the study.
• Age ≥ 18 years

Критерии исключения

• Cardiogenic shock
• Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
• Target lesion located in left main trunk or bypass graft.
• Additional coronary intervention planned within 30 days of the procedure.
• Non-successful treatment of other lesion(s) during the same procedure
• Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
• Contraindications to any components of the investigational devices or dual antiplatelet therapy
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial or participation in any other study at the time of enrollment.
• Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
• Patient's inability to fully comply with the study protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 4 центра

• Universitätsklinikum Frankfurt — Frankfurt am Main
• Elisabeth-Krankenhaus Essen GmbH — Essen
• Universitätsklinikum Hamburg-Eppendorf — Hamburg
• Deutsches Herzzentrum München — Munich

Испания · 1 центр

• Hospital Universitario de La Princesa Madrid — Madrid

Публикации

• Simonetti F, Voll F, Alfonso F, Grasser C, Janisch M, Joner M, Kessler T, Kuna C, Leistner DM, Lenz T, Presch A, Rheude T, Sager H, Schunkert H, Starnecker F, Wiebe J, Kastrati A, Cassese S, Xhepa E. Intracoronary Stenting and Restenosis - Randomized Trial of Drug-Eluting Stent Implantation or Drug-Coated Balloon Angioplasty According to Neointima Morphology in Drug-Eluting Stent REstenosis 5: Rat PMID 40588613

Идентификаторы

NCT: NCT05544864 · GE IDE no. BA00219

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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