DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

Официальное название

DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

Обзор

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Подробное описание

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Вмешательства

• Устройство Drug Coated Balloon (DCB)
  Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)
• Устройство Drug Eluting Stent (DES)
  Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

Первичные конечные точки

• Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L). [Срок оценки: 8 months]

Вторичные конечные точки (5)

• Comparison of percentage of angiographic restenosis by quantitative coronary [Срок оценки: 8 months]
• Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography [Срок оценки: 8 months]
• Comparison of the minimum luminal area of the treated segment by optical coronary tomography [Срок оценки: 8 months]
• Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group [Срок оценки: 8 months]
• Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months [Срок оценки: 8 months]

Критерии участия

Критерии включения

Patients who meet all of the following conditions are included.

• Patients aged ≥ 18 years and;
• Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
• Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
• Patients who have been informed of the characteristics of the study and have provided their written informed consent.

Критерии исключения

Patients who meet at least one of the following conditions are excluded:

• Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
• Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.
• Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.
• Patients who received a combination of DES and DCB in the same vessel
• Patients with glomerular filtration rate <30 ml/min/ 1.73 m2
• Patients with body mass index >35 (may affect the evaluation qualitative diameter of the coronary artery).
• Patients with symptomatic congestive heart failure.
• Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
• Patients with heart transplant.
• Patients with anemia (Hb <12 g/dL in men and <10 g/dL in women).
• Patients, women of childbearing age with a positive pregnancy test.
• Pregnant female patients.
• Patients included in other clinical trials with active follow-up.

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

Испания · 8 центров

• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital Universitario de Cabueñes — Gijón
• Hospital Universitario Juan Ramón Jiménez — Huelva
• Hospital Universitario de Leon — León
• Hospital Universitario Lucus Augusti — Lugo
• Hospital Universitario Central de Asturias — Oviedo
• Hospital Provincial de Pontevedra — Pontevedra
• Hospital Universitari de Tarragona Joan XXIII — Tarragona

Публикации

• Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046. PMID 32138967
• Nakamura T, Brott BC, Brants I, Panchal D, Li J, Chen JP, King SB 3rd, Chronos N, Hou D. Vasomotor function after paclitaxel-coated balloon post-dilation in porcine coronary stent model. JACC Cardiovasc Interv. 2011 Feb;4(2):247-55. doi: 10.1016/j.jcin.2010.08.028. PMID 21349465
• Gutierrez E G-LJ, Escaned J, Cruz I, Ojeda S, Romaguera R, Moreno R. Valoración de la función endotelial y provocación de vasoespasmo coronario mediante infusión intracoronaria de acetilcolina. Documento técnico de la ACI-SEC. REC Interv Cardiol. 2021;3(4):286-296.
• Gomez-Lara J, Oyarzabal L, Ortega-Paz L, Brugaletta S, Romaguera R, Salvatella N, Roura G, Rivero F, Fuentes L, Alfonso F, Otaegui I, Vandeloo B, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary Endothelium-Dependent Vasomotor Function After Drug-Eluting Stent and Bioresorbable Scaffold Implantation. J Am Heart Assoc. 2021 Nov 16;10(22):e022123. doi: 10.1161/JAHA.121.022123. Epub PMID 34729992
• Brugaletta S, Heo JH, Garcia-Garcia HM, Farooq V, van Geuns RJ, de Bruyne B, Dudek D, Smits PC, Koolen J, McClean D, Dorange C, Veldhof S, Rapoza R, Onuma Y, Bruining N, Ormiston JA, Serruys PW. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polym PMID 22507972

Идентификаторы

NCT: NCT06448637 · EPIC37-DEBORA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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