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Completed

NCT Number: NCT01674803

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion (BIO-RESORT)

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 biodegradable 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 biodegradable polymer DES are increasingly used in clinical practice, there is no data available from head-to-head comparisons between biodegradable and contemporary third generation durable polymer DES.

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Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Coronary Restenosis Coronary Stenosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Minimum age of 18 years.
  • Significant coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement.
  • Capable of providing informed consent.
  • Patients with all clinical syndromes will be enrolled without any exclusion based on number, type, location, or length of lesions to be treated.

Exclusion criteria

  • Known intolerance to components of one of the stents that will be investigated or known intolerance to antithrombotic and/or anticoagulant therapy that prevents adherence to dual antiplatelet therapy.
  • Planned elective surgical procedure necessitating interruption of dual antiplatelet therapy during the first 6 months after randomization.
  • Participation in another randomized drug or device trial before reaching primary endpoint.
  • Adherence to scheduled follow-up is unlikely or life expectancy assumed to be less than 1 year.
  • Known pregnancy

Treatment and study plan

Orsiro

Device

biodegradable polymer sirolimus eluting stent

Synergy

Device

biodegradable polymer everolimus eluting stent

Resolute Integrity

Device

durable polymer zotarolimus-eluting stent

Primary outcomes

  1. Target vessel failure (TVF)

    Time frame: 1 year

    Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.

Secondary outcomes

  1. Target lesion failure (TLF)

    Time frame: 1 year

    Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization

Sponsors and collaborators

Lead sponsor

Foundation of Cardiovascular Research and Education Enschede

Other

Registry information

Official study title

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an All COmeRs PopulaTion: Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

Acronym: BIO-RESORT

Important dates

Study start
2012
Primary completion
2016
Study completion
2020
First posted
Aug 29, 2012
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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