Status:
UNKNOWN
Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Coronary Artery Disease
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the efficacy and performance in an all-comers contemporary population of the ABSORB bioresorbable vascular scaffolds (BVS) strategy versus the XIENCE family (XIENCE PRIME or XIENCE Xpediti...
Detailed Description
The AIDA trial is a prospective, randomized (1:1), active control, single blinded, four-center, all-comers, non-inferiority trial. A total of 1845 patients were enrolled. The study population includes...
Eligibility Criteria
Inclusion
- 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.
- Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS strategy and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
Exclusion
- Subject is younger than 18 years of age
- Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
- 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 diameter size 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 length greater than 70 mm and/or overlapping of four or more scaffolds/stents.
- 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.
- 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)
- 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 yet reached 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
1845 Patients enrolled
Trial Details
Trial ID
NCT01858077
Start Date
August 1 2013
End Date
December 1 2020
Last Update
January 9 2019
Active Locations (5)
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1
AMC
Amsterdam, North Holland, Netherlands, 1105 AZ
2
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
3
Albert Schweitzer Hospital
Dordrecht, Netherlands
4
TerGooi Hospital
Hilversum, Netherlands