Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial

Last updated: January 8, 2019
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Chest Pain

Heart Defect

Treatment

N/A

Clinical Study ID

NCT01858077
COR 10341
AIDA trial
  • Ages > 18
  • All Genders

Study 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 Xpedition) everolimus eluting coronary stent system in the treatment of coronary lesions.

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

Total Participants: 1845
Study Start date:
August 01, 2013
Estimated Completion Date:
December 31, 2020

Study 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 both simple and complex lesions, as well as stable and acute coronary syndrome patients. The follow-up will continue for 5 years including clinical endpoint characteristics.

Connect with a study center

  • AMC

    Amsterdam, Noord-Holland 1105 AZ
    Netherlands

    Site Not Available

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam,
    Netherlands

    Site Not Available

  • Albert Schweitzer Hospital

    Dordrecht,
    Netherlands

    Site Not Available

  • TerGooi Hospital

    Hilversum,
    Netherlands

    Site Not Available

  • Medical Center Leeuwarden

    Leeuwarden,
    Netherlands

    Site Not Available

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