Amsterdam Investigator-initiateD Absorb strategy all-comers trial
- Conditions
- coronary atherosclerosiscoronary artery disease10011082
- Registration Number
- NL-OMON41656
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1790
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite endpoint Target Vessel Failure (TVF) at 2 years:<br /><br>- Cardiac death<br /><br>- Myocardial infarction (MI) according to Third Universal Myocardial Infarction<br /><br>definitions (unless clearly attributable to a nontarget vessel)<br /><br>- Target Vessel revascularization</p><br>
- Secondary Outcome Measures
Name Time Method