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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01674803
First Posted: August 29, 2012
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
  Purpose
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
Acute Coronary Syndrome Angina Pectoris Angina, Unstable Myocardial Infarction Coronary Artery Disease Coronary Stenosis Coronary Restenosis Device: Orsiro Device: Synergy Device: Resolute Integrity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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)

Further study details as provided by prof. C. von Birgelen, Thorax Centrum Twente:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 3514
Actual Study Start Date: December 21, 2012
Estimated Study Completion Date: August 2019
Primary Completion Date: August 24, 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674803


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: prof. C. von Birgelen, Professor C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier: NCT01674803     History of Changes
Other Study ID Numbers: BIO-RESORT
First Submitted: August 21, 2012
First Posted: August 29, 2012
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by prof. C. von Birgelen, Thorax Centrum Twente:
drug-eluting stent
zotarolimus
everolimus
sirolimus
all comers population
target vessel failure
coronary artery disease
durable polymer
biodegradable polymer

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Coronary Stenosis
Coronary Restenosis
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms