Phase
Condition
Hypercholesterolemia
Chest Pain
Heart Defect
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is an acceptable candidate for treatment with a drug-eluting stent inaccordance with the applicable guidelines on percutaneous coronary interventions andthe Instructions for Use of the ABSORB BVS strategy and XIENCE family.
Subject is able to verbally confirm understanding of risks, benefits and treatmentalternatives of receiving the ABSORB BVS strategy and he/she or his/her legallyauthorized representative provides written informed consent prior to any ClinicalInvestigation related procedure, as approved by the appropriate Ethics Committee.
Exclusion
Exclusion Criteria:
Subject is younger than 18 years of age
Subject has a true bifurcation lesion where a priori two scaffold/stent strategy isplanned.
Unsuccessful predilation of one or more of the planned lesion to be treated.
Planned treatment of in-stent restenosis of a previously placed metallic stent.
Subject has one or more lesion planned to be treated with a scaffold/stent diametersize smaller than 2.5 mm or greater than 4.0 mm.
Subject has one or more lesion planned to be treated with a stent/scaffold lengthgreater than 70 mm and/or overlapping of four or more scaffolds/stents.
Subject has known hypersensitivity or contraindication to aspirin, both heparin andbivalirudin, 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 contrastsensitivity that cannot be adequately pre-medicated.
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 musthave a negative pregnancy test done within 28 days prior to the index procedure andcontraception must be used during participation in this trial)
Subjects with a limited life expectancy less than one year.
Subjects with factors that impede clinical follow-up (e.g. no fixed abode).
Subject is already participating in another clinical investigation that has not yetreached its primary endpoint.
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 Description
Connect with a study center
AMC
Amsterdam, Noord-Holland 1105 AZ
NetherlandsSite Not Available
Onze Lieve Vrouwe Gasthuis
Amsterdam,
NetherlandsSite Not Available
Albert Schweitzer Hospital
Dordrecht,
NetherlandsSite Not Available
TerGooi Hospital
Hilversum,
NetherlandsSite Not Available
Medical Center Leeuwarden
Leeuwarden,
NetherlandsSite Not Available

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