Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent
COMPARE-II
1 other identifier
interventional
2,700
4 countries
11
Brief Summary
This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Jan 2009
Longer than P75 for phase_4 coronary-artery-disease
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
November 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJanuary 30, 2014
January 1, 2014
3.3 years
October 28, 2010
January 29, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Major adverse coronary events
composite of cardiac death, non fatal myocardial infarction and target vessel revascularization
12 months
Secondary Outcomes (7)
Major adverse coronary events
12 months
Safety of stenting with drug eluting stents
5 years
Target lesion revascularization
5 years
Late major adverse coronary events
5 years
Major adverse coronary events in subgroups
5 years
- +2 more secondary outcomes
Study Arms (2)
the everolimus eluting ® stent
ACTIVE COMPARATORthe everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent
Biolimus A9 stent
ACTIVE COMPARATORthe Biolimus A9 eluting NOBORI® stent
Interventions
stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent
stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent
Eligibility Criteria
You may qualify if:
- The patient is at least 18 years old and has a life expectancy of 5 years.
- Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
- Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
- Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
- Informed consent
You may not qualify if:
- Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
- Expected major surgery within 30 days (these patients will receive bare metal stents)
- Cardiogenic shock (Kilip class 4)
- Previous PCI procedures with implantation of drug eluting stents within 1 year.
- Expected loss for follow up
- Enrollment in an investigative stent study with different stents
- Inability to implant Nobori or Xience-V / Promus stent(s)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Onassis cardiac Surgery Centre
Athens, Greece
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Maasstad Hospital
Rotterdam, Netherlands
Complejo Hospitalario Universitario Juan Canalejo
A Coruña, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Virgen Arrixaca
Murcia, Spain
Hospital Clinico universitario de Santiago de Compostella
Santiago de Compostela, Spain
Kantonsspital Aarau
Aarau, Switzerland
Hopital Cantonal de Fribourg
Fribourg, Switzerland
Related Publications (2)
Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.
PMID: 26196753DERIVEDSmits PC, Hofma S, Togni M, Vazquez N, Valdes M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013 Feb 23;381(9867):651-60. doi: 10.1016/S0140-6736(12)61852-2. Epub 2013 Jan 30.
PMID: 23374650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pieter C Smits, MD, PHD
Maasstad Ziekenhuis
- STUDY CHAIR
A Serra, MD
Hospital del Mar
- STUDY CHAIR
A J van Boven, MD, PHD
Medisch Centrum Leeuwarden
- STUDY CHAIR
J J Goy, MD
Hopital Cantonal de Fribourg
- STUDY CHAIR
V Voudris, MD
Onassis Heart Centre, Athens
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
November 3, 2010
Study Start
January 1, 2009
Primary Completion
May 1, 2012
Study Completion
December 1, 2015
Last Updated
January 30, 2014
Record last verified: 2014-01