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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente Identifier:
First received: August 21, 2012
Last updated: July 27, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Myocardial Infarction
Coronary Artery Disease
Coronary Stenosis
Coronary Restenosis
Device: Orsiro
Device: Synergy
Device: Resolute Integrity
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Further study details as provided by Cardio Research Enschede BV:

Primary Outcome Measures:
  • Target vessel failure (TVF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Target vessel failure is a combined endpoint of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization.

Secondary Outcome Measures:
  • Target lesion failure (TLF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Target lesion failure is a combined endpoint of cardiac death, target vessel related myocardial infarction, and clinically driven target lesion revascularization

Estimated Enrollment: 3540
Study Start Date: December 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Orsiro Device: Orsiro
biodegradable polymer sirolimus eluting stent
Active Comparator: Synergy Device: Synergy
biodegradable polymer everolimus eluting stent
Active Comparator: Resolute Integrity Device: Resolute Integrity
durable polymer zotarolimus-eluting stent


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01674803

Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Sponsors and Collaborators
Cardio Research Enschede BV
  More Information

No publications provided by Cardio Research Enschede BV

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: prof. C. von Birgelen, Professor C. von Birgelen, Thorax Centrum Twente Identifier: NCT01674803     History of Changes
Other Study ID Numbers: BIO-RESORT
Study First Received: August 21, 2012
Last Updated: July 27, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Cardio Research Enschede BV:
drug-eluting stent
all comers population
target vessel failure
coronary artery disease
durable polymer
biodegradable polymer

Additional relevant MeSH terms:
Acute Coronary Syndrome
Angina Pectoris
Angina, Unstable
Coronary Artery Disease
Coronary Disease
Coronary Restenosis
Coronary Stenosis
Myocardial Infarction
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Heart Diseases
Signs and Symptoms
Vascular Diseases processed this record on November 30, 2015