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

Completed

Conditions: Ischemic heart disease - risk for restenosis
10011082

Registration Number: NL-OMON54699

Lead Sponsor: Maasstadziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 460

Inclusion Criteria

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)

Exclusion Criteria

•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
artery)