NL-OMON54699已完成不适用
Compare Absorb ABSORB bioresorbable scaffold vs. Xience metallic stent for prevention of restenosis following percutaneous coronary intervention in patients at high risk of restenosis. ;Annex study of in-stent restenosis COMPARE ABSORB ISR study: A single-arm, annex study of patients with in-DES restenotic lesions requiring PCI and treated with Absorb BVS - Compare Absorb, Compare Absorb ISR
Maasstadziekenhuis0 个研究点目标入组 460 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 460
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients (18-80 years old) with at least one of the following:
- •i) High-risk characteristics for restenosis
- •Medically treated Diabetes and/or multivessel disease of which more than one
- •de-novo target lesion to be treated with the study scaffold/stent
- •ii) Complex target lesion
- •Single de-novo target lesion satisfying at least one of the following:
- •Lesion length >28 mm
- •Small vessels: Target lesion reference vessel diameter between 2.5-2.75 mm
- •Lesion with pre-existing total occlusion (pre-procedural TIMI = 0)
- •*Pre-existing* occlusion is supposed to be present before procedure and does
- •not include the culprit lesion in the setting of acute myocardial infarction.
- •Bifurcation with single stent strategy
- •Patients with in-stent restenosis (ISR) of a drug-eluting stent are admitted to
- •a separate annex study protocol: Compare Absorb ISR, Inclusion criteria
- •Diabetic substudy
- •Diabetes Mellitus
- •All other general inclusion criteria according to Compare Absorb main study
- •eligibility criteria., inclusion / exclusion criteria Smart Follow up substudy
- •- As same as the the Compare Absorb main study, Inclusion criteria in-stent
- •restenosis annex study Compare Absorb ISR
- •Patients who are excluded from the main Compare Absorb randomised study, due
- •to the presence of in-DES restenosis
- •Patients aged 18-80 years
- •high risk of restenosis due to the presence of up to two in-DES restenosis
- •lesions in one or two different epicardial vessels that could be treated with
- •Absorb scaffold(s)
排除标准
- •Age <18 years or >75 years
- •Renal insufficiency (GFR/MDRD <45 ml/min)
- •Known comorbidities which make patients unable to complete 5-year follow-up
- •Known non-adherence to DAPT
- •Patients on oral anticoagulation
- •Cardiogenic Shock (Killip >2)
- •LVEF <30%
- •* Patients at high bleeding risk who are not suitable for long-term DAPT
- •* Pregnant woman
- •Following lesion characteristics:
- •--Target lesion reference vessel diameter (RVD) < 2.5 and > 4 mm
- •--STEMI with RVD of >3.5mm of the culprit target lesion
- •--Target lesion with in-stent/scaffold thrombosis
- •--Graft lesions as target lesions
- •--Aorto-ostial lesion(s)
- •--Left main lesion
- •--Severe tortuosity of target vessel
- •--In-scaffold/in-stent restenosis
- •--Bifurcation target lesion with intended 2 stent/scaffold strategy,
- •Exclusion criteria Diabetic sub-study are the same as for the main study,
- •Exclusion criteria in-stent restenosis annex study Compare Absorb ISR
- •Similar to the main Compare Absorb study except for the exclusion for
- •in-stent restenosis
- •Additional lesion exclusion criteria:
- •Bare metal stent restenosis requiring intervention in the target vessel(s)
- •Initial DES size of < 2.5 mm, or in the absence of information on previous
- •DES size, target vessel diameter < 2.5 mm
- •Previous 2 stent technique in the target lesion if it is a bifurcation lesion
- •Recurrent in-DES restenosis in the target vessel
- •More than one layer of metallic DES/BMS at the target lesion site
- •Non-target lesion and target lesion in the same epicardial coronary artery
- •(right coronary artery, left circumflex artery or left anterior descending
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