Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents

Last updated: February 2, 2017
Sponsor: Thorax Centrum Twente
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Vascular Diseases

Hypercholesterolemia

Chest Pain

Treatment

N/A

Clinical Study ID

NCT02508714
P15-19
  • Ages > 18
  • All Genders

Study Summary

The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients of 18 years and older, requiring PCI for the treatment of significantcoronary artery or bypass graft lesions, being eligible for treatment with drugeluting stents according to clinical guidelines and/or the operators' judgement, andcapable of providing informed consent.

  • Patients with all clinical syndromes will be enrolled without any exclusion based onnumber, type, location or length of lesions to be treated.

Exclusion

Exclusion Criteria:

  • Known intolerance to components of one of the study DES, or known intolerance toantithrombotic and/or anticoagulant therapy that prevents adherence to any dualanti-platelet therapy (DAPT).

  • Planned elective surgical procedure necessitating interruption of DAPT during thefirst 3 months after randomization.

  • Participation in another randomized cardiovascular device trial or randomizedpharmacological study related to antithrombotic and/or anticoagulant therapy beforereaching the primary endpoint.

  • Known pregnancy, adherence to scheduled follow-up is unlikely, or life expectancy isassumed to be less than 1 year

Study Design

Total Participants: 2470
Study Start date:
October 07, 2016
Estimated Completion Date:
March 31, 2019

Study Description

rationale: The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity. However, the first generation of these devices had no positive impact on the mortality after PCI (compared to bare metal stents), which was greatly attributed to a somewhat increased incidence of late and very late stent thrombosis. Concerns about the role of durable polymers as a potential trigger of inflammation and finally adverse events also led to the development of DES with bioresorbable coatings, which leave after degradation of the coating only a bare metal stent in the vessel wall that does not induce an inflammatory response. While such bioresorbable polymer DES are increasingly used in clinical practice, data from head-to-head comparisons between bioresorbable polymer DES with a contemporary highly flexible new generation permanent polymer coated DES.

Aim:

The aim of the study is to compare the outcome of the bioresorbable polymer coated stent (ORSIRO) and a new generation permanent polymer coated stent (RESOLUTE ONYX) in an all-comers patient population and non-inferiority setting.

Study design:

The study is a prospective, randomized, single-blinded, multicentre trial with 1:1 randomization for drug-eluting stent type, stratified for gender and the presence of diabetes mellitus.

Study population:

Patients who require percutaneous coronary intervention (PCI) for the treatment of coronary stenoses with an indication for DES use, according to current guidelines and/or the operators clinical judgement. All clinical syndromes will be included. A total of 2,470 patients will be included.

Intervention:

One group will receive the ORSIRO stent, the other group will receive the RESOLUTE ONYX stent. All other intervention and procedural characteristics are similar.

Primary study outcome:

Incidence of target vessel failure (TVF) at 1 year follow-up (according to ARC definitions). Components of the primary endpoint in hierarchical order: - Cardiac death: all deaths are considered cardiac, unless an unequivocal non-cardiac cause can be established. - Target vessel related myocardial infarction (MI) that is Q-wave or non-Q-wave, that can be related to the target vessel or cannot be related to another vessel. - Clinically driven repeated target vessel revascularization by means of PCI or coronary artery bypass grafting (CABG).

Connect with a study center

  • CHU Charleroi

    Charleroi,
    Belgium

    Site Not Available

  • Jessa Ziekenhuis

    Hasselt,
    Belgium

    Site Not Available

  • Rambam

    Haifa,
    Israel

    Site Not Available

  • Haga Ziekenhuis

    Den Haag, Zuid Holland 2504 LN
    Netherlands

    Site Not Available

  • Rijnstate Hospital

    Arnhem,
    Netherlands

    Site Not Available

  • Treant Zorggroep

    Emmen,
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Site Not Available

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