Primary Objective: To compare the strategies of treatment with 1. ABSORB everolimus eluting bioresorbable vascular scaffolds and 2. Xience everolimus eluting coronary stent system in a non-inferiority all-comers trial.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
The ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) is composed
of the polymer poly (L-lactide) (PLLA) backbone which is expected to be fully
absorbed in 18 to 24 months. Previous registry studies on the ABSORB BVS showed
MACE rates and late lumen losses comparible with the contemporary third
generation drug-eluting stents, which are considered as the standard of care in
our institution. Currently, a randomized controlled trial comparing ABSORB BVS
with the Xience drug-eluting metallic stent is running, the ABSORB II. In this
trial, however, only subject with a small range of stent sizes and relatively
simple lesion complexity in an elective setting were included. Therefore, a
study is needed in which also patients with lesions with more complexity and in
the acute setting should be included and compared with a contemporary
drug-eluting stent. We will perform a randomised controlled trial in which we
will compare the ABSORB BVS with the Xience drug-eluting metallic stent in an
all-comer patients population
Study objective
Primary Objective: To compare the strategies of treatment with 1. ABSORB
everolimus eluting bioresorbable vascular scaffolds and 2. Xience everolimus
eluting coronary stent system in a non-inferiority all-comers trial.
Study design
Prospective, randomized (1:1), active control, single blinded, single-center,
all-comers, non-inferiority trial comparing ABSORB BVS strategy with XIENCE
family strategy.
Intervention
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 interventions will be done with the index
strategy device up to 5 years.
Study burden and risks
Since two strategies will be compared which are both practised in daily
clinical practice and in both strategies CE-marked devices will be used, we
consider all PCI-related risk and burdens not to be related with participation
in this study. Potential benefits of being randomised to Xience could be that
with Xience there is extensive experience and the design of the stent in
combination with its Everolimus drug results in low restenosis rates. The
potential benefit of being randomised to ABSORB BVS is that it will be absorbed
in 18 to 24 months so there will be no foreign body left behind for the rest of
patient's life. Another potential burden for the patient is that he will be
called 7 times in total.
Meibergdreef 9
AZ 1105
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Meibergdreef 9
AZ 1105
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01858077 |
| CCMO | NL43867.018.13 |