Leave Nothing Behind Study Which Compares DCB With Bail Out BRS Versus BRS Strategy Alone

Официальное название

Multi-center, Open-label, Prospective, Randomized Study to Show Long-term Efficacy of DCB Treatment With Bail-out BRS in Comparison to BRS Treatment of De-novo Native Coronary Artery Lesions in a Relatively Young PCI Population.

Обзор

The goal of this study is to investigate the equivalence in early and long-term efficacy between the two "Leave nothing behind strategies" (Drug-Coated Baloon \[DCB\] strategy with bail-out BioResorbable Scaffold \[BRS\] versus BRS strategy) of de-novo native coronary artery lesions in a relatively young Percutaneous Coronary Intervention (PCI) population, to be more specific, Patients with Chronic Coronary Syndromes (CCS) and Acute Coronary Syndrome (ACS) (Non-ST-segment Elevation Myocardial Infarction \[NSTEMI\] and Unstable angina) between 18-68 years of age scheduled for PCI. The main questions aim to answer are: DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 12 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has noninferior angiographic in-segment net gain at 13 months compared to BRS strategy? DCB strategy with bail-out BRS implantation has equivalent clinical outcomes at 60 months compared to BRS strategy? Participants will be followed at: 1. st FU visit - 1 month (in hospital) 2. nd FU visit - 6 months (telephone) 3. rd FU visit - 365 days±15 days (telephone) - 1Y Primary efficacy endpoint 4. th FU visit - 395 days±15 days (in hospital) co-primary efficacy endpoint for the angiographic substudy 5. th FU visit - 730 days±30 days (telephone call) - 2Y 6. th FU visit - 1095 days±30 days (telephone call) - 3Y 7. th FU visit - 1460 days±30 days (telephone call) - 4Y 8. th FU visit- 1825 days±30 days (telephone call) - 5Y

Подробное описание

The Leave Nothing Behind Study is an is an investigator-initiated trial. The Primary efficacy endpoint is target-vessel failure (TVF), defined as the composite of cardiovascular death, target-vessel myocardial infarction or ischemia-driven target-vessel revascularization (TVR) at 12 months.

Co-primary efficacy endpoint (angiographic substudy) is the in-segment net gain at 13 months.

Investigators aim to enroll 2256 patients in the main study and 196 patients in the angiographic substudy.

Вмешательства

• Процедура Angioplasty with DCB (bail-out BRS)
  Angioplasty starts with lesion preparation in both arms with a PTCA balloon catheter. The lesion is treated with the Mozec SEB through femoral or brachial artery. The DCB should be delivered to the target lesion within 120 seconds of insertion into the guide catheter. Under fluoroscopic visualization, the DCB is inflated at least 30 seconds (single inflation). If the results are insufficient, multiple inflation is permitted. If despite appropriate delivery and inflation of the DCB, the results
• Процедура Angioplasty with BRS
  Bail-out BRS is performed through femoral or brachial artery. BRS implantation is guided by OCT, if available. After correct positioning, the BRS is deployed slowly, i.e. 10 seconds/atm up to 4 atm, then 5 seconds/atm up to nominal pressure or higher until desired expansion is obtained. After desired expansion obtained, pressure is maintained for 30 seconds before balloon deflation. After BRS implantation, OCT is performed, if available.

Первичные конечные точки

• Target-vessel Failure (TVF) [Срок оценки: From enrollment to the end of treatment at 12 months]

Вторичные конечные точки (4)

• Target-Vessel Failure (TVF) at 2, 3, 4 and 5 years. [Срок оценки: From enrollment to the end of treatment at every year from 2 years until 5 years follow-up]
• Target-Lesion Failure (TLF) [Срок оценки: From enrollment to the end of treatment every year until end of 5 years]
• (Bleeding Academic Research Consortium) BARC 2, 3 or 5 bleedings [Срок оценки: From enrollment to the end of treatment every year until end of 5 years]
• Net Adverse Clinical Event (NACE) [Срок оценки: From enrollment to the end of treatment every year until end of 5 years]

Критерии участия

Критерии включения

• Patients aged ≥ 18 years ≤ 68 years
• Single vessel or multivessel disease with low to moderate complex de-novo native coronary artery lesions up to 30 mm length and reference vessel diameter 2.75-4.0 mm
• Maximum of 3 target lesions
• Maximal cumulative lesion length of all treated lesions 80 mm
• Signed informed consent for participation in the study

Критерии исключения

• ST-segment Elevation Myocardial Infarction (STEMI) treatment at index or in the previous 48 hours
• Severe calcified lesions
• Bifurcations lesions with planned 2 device strategy
• Left-Main (LM) disease ≥ 50% diameter stenosis
• More than 3 target lesions
• Renal insufficiency with Glomerular Filtration Rate (GFR) < 45 ml/min
• Life expectancy less than 1 year
• Known hypersensitivity or allergy to aspirin or P2Y12 receptor inhibitors
• Incapable of providing written informed consent
• Pregnant or breastfeeding women
• Under judicial protection, tutorship, or curatorship
• Participation in another trial

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

Эстония · 1 центр

• Põhja-Eesti Regionaalhaigla — Tallinn

Публикации

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• Seth A, Onuma Y, Chandra P, Bahl VK, Manjunath CN, Mahajan AU, Kumar V, Goel PK, Wander GS, Kaul U, Ajit Kumar VK, Abizaid A, Serruys PW. Three-year clinical and two-year multimodality imaging outcomes of a thin-strut sirolimus-eluting bioresorbable vascular scaffold: MeRes-1 trial. EuroIntervention. 2019 Sep 20;15(7):607-614. doi: 10.4244/EIJ-D-19-00324. PMID 31147308
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Идентификаторы

NCT: NCT07038408 · Leave Nothing Behind

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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