coronary artery disease coronary atherosclerosis
Conditions
Interventions
The Index Strategy is:
Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold
strategy (referred to as ABSORB BVS)
The control strategy is:
In the course of the study all repeat
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: o Subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions and the Instructions for Use of the ABSORB BVS strategy and XIENCE family. o Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/sheprovides written or in the event of STEMI oral informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Exclusion criteria
Exclusion criteria: o Subject is younger than 18 years of age o Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned. o Unsuccessful predilation of one or more of the planned lesion to be treated. o Planned treatment of in-stent restenosis of a previously placed metallic stent. o Subject has one or more lesion planned to be treated with a scaffold/stent diameter size smaller than 2.5 mm or greater than 4.0 mm. o Subject has one or more lesion planned to be treated with a stent/scaffold length greater than 70 mm and/or overlapping of four or more scaffolds/stents. o Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated. o Subjects pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial) o Subjects with a limited life expectancy less than one year. o Subjects with factors that impede clinical follow-up (e.g. no fixed abode). o Subject is already participating in another clinical investigation that has not yet reached its primary endpoint. o Subject is belonging to a vulnerable population (per investigator*s judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint Target Vessel Failure (TVF) at 2 years: - Cardiac death - Myocardial infarction (MI) according to Third Universal Myocardial Infarction definitions (unless clearly attributable to a nontarget vessel) - Target Vessel revascularization | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute success o Device success: Successful delivery and deployment of the first study scaffold/stent the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 20% by QCA and TIMI 3 flow grade of the treated vessel. o Procedural success: Achievement of final in-scaffold/stent residual stenosis of less than 20% by QCA and TIMI 3 flow grade of the treated vessel with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay. Clinical endpoints (adjudicated) o Scaffold/Stent Thrombosis according to ARC definitions (acute, subacute, and late/definite and probable) at 30 days, 1, 2, 3, 4 and 5 years follow-up. o Target lesion failure (Device-oriented endpoint) according to ARC definitions (cardiac death, MI (not clearly attributable to a nontarget vessel), target lesion revascularization) at 30 days, 1, 2, 3, 4 and 5 years follow-up o All coronary revascularizations o Major adverse cardiac events (Patient-oriented composite) according to ARC definitions (all-cause mortality, any MI, any repeat revascularization) at 30 days, 1, 2, 3, 4 and 5 years follow-up. o Individual clinical endpoints according to ARC definitions (at 30 days, 1, 2, 3, 4 and 5 years follow-up). Components: - Death (Cardiac, Vascular, Non-Cardiovascular) - Myocardial Infarction (Q-wave MI and non Q-wave MI/Target vessel MI and non-target vessel MI) - Target Lesion Revascularization (TLR): - Target Vessel Revascularization (TVR) - Non-Target Vessel Revascularization (NTVR) | — |
Countries
Netherlands
Outcome results
None listed