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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Cardio Research Enschede BV
Sponsor:
Information provided by (Responsible Party):
prof. C. von Birgelen, Thorax Centrum Twente
ClinicalTrials.gov Identifier:
NCT01674803
First received: August 21, 2012
Last updated: August 27, 2012
Last verified: August 2012
  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 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: November 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674803

Contacts
Contact: C. von Birgelen, MD,PhD,Prof 0031534872105 cre@mst.nl
Contact: H. Verheij, RS 0031534872105 cre@mst.nl

Locations
Netherlands
Albert Schweitzer Ziekenhuis Not yet recruiting
Dordrecht, Netherlands
Contact    0786541111      
Principal Investigator: A. Dirkali, MD         
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 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
Study First Received: August 21, 2012
Last Updated: August 27, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

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

ClinicalTrials.gov processed this record on August 27, 2014