Contact information
Type
Scientific
Primary contact
Mr Danny Detiege
ORCID ID
Contact details
Research Park Zone 2 Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium
+32 (0)16 38 13 80
danny.detiege@terumo-europe.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
T109E2
Study information
Scientific title
NOBORI 2: a prospective, multi-centre, observational study of the Nobori™ drug eluting stent system
Acronym
NOBORI 2
Study hypothesis
Primary objective:
To validate, in a real life setting, the safety and effectiveness of the Nobori™ drug eluting stent (DES) system previously observed in randomised trials.
Secondary objectives:
1. To assess the long term safety of the Nobori™ stent in a fully representative patient population
2. To assess the performance of the Nobori™ stent in various patient/lesion subpopulations
3. To identify rationale for further randomised studies in specific subsets
4. To assess the possible benefit of bioresorbable polymer on long term safety
Ethics approval
1. Freiburger ethik kommission (Germany), 17/03/2008
2. Ziekenhuis Oost Limburg and Onze Lieve Voruw Ziekenhuis Aalst (Belgium), 29/04/2008
3. Bad Oeynhausen (Germany), 28/04/2008
All other participating countries have submitted in April through June to all participating hospital Ethics Committees wherever such requirement exists prior to enrolment of patients. Last site start up expected July 2008.
Study design
Observational single-arm prospective multi-centre study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Atheromatous coronary artery disease
Intervention
Observational collection of routine hospital practice, clinical follow-up for monitoring of adverse and major cardiac events (death, infarction, re-interventions on target lesion, stent thrombosis), documentation of cardiac medication regimen, laboratory results if performed in routine practice. Follow up at 1, 6 and 12 months, and yearly up to 5 years.
Intervention type
Device
Phase
Drug names
Primary outcome measures
Device oriented composite endpoint, defined as cardiac death, myocardial infarction (Q-wave and non-Q-wave not clearly attributable to non-target vessel) and clinically driven target lesion revascularisation at 12 months post-procedure.
Secondary outcome measures
1. Device oriented composite endpoint, defined as cardiac death, myocardial infarction (MI) (Q-wave and non-Q-wave not clearly attributable to non-target vessel) and clinically driven target lesion revascularisation at 1 and 6 months, 2, 3, 4 and 5 years post-procedure
2. Patient oriented composite endpoint defined as any cause mortality, MI (Q wave and non-Q wave), or any clinically driven target vessel revascularisation at 1, 6 and 12 months and at 2, 3, 4 and 5 years
3. Death and MI at 1, 6 and 12 months, 2, 3, 4 and 5 years
4. Death and post-procedural MI at 1, 6 and 12 months, 2, 3, 4 and 5 years
5. Stent thrombosis (definite and probable according to Academic Research Consortium [ARC] definitions) at 1, 6 and 12 months, 2, 3, 4 and 5 years
6. Primary stent thrombosis (definite and probable according to ARC definitions) at 1, 6 and 12 months, 2, 3, 4 and 5 years
7. Secondary stent thrombosis (definite and probable according to ARC definitions) at 1, 6 and 12 months, 2, 3, 4 and 5 years
8. Duration of dual antiplatelet therapy
9. Death, post-procedural MI and stent thrombosis rate during the course of dual antiplatelet therapy versus the same events after cessation of dual antiplatelet therapy
10. Clinically driven target lesion revascularisation (TLR) at 1, 6 and 12 months, 2, 3, 4 and 5 years
11. Clinically driven target vessel revascularisation (TVR) at 1, 6 and 12 months, 2, 3, 4 and 5 years
12. Total revascularisation rate (clinically and non clinically driven) at 1, 6 and 12 months, 2, 3, 4 and 5 years
13. Device success defined as the attainment of less than 30% residual stenosis by visual assessment using the Nobori™ stent only
14. Lesion success defined as the attainment of less than 30% residual stenosis by visual assessment using any percutaneous method
15. Procedure success defined as achievement of a final diameter stenosis of less than 30% by visual assessment using any percutaneous method, without the occurrence of death, Q wave or non-Q wave MI, or repeat revascularisation of the target lesion during the hospital stay
All above mentioned endpoints in specific subgroups enrolling sufficient number of patients.
Overall trial start date
01/04/2008
Overall trial end date
30/11/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patient is at least 18 years old, either sex
2. The patient is, according to hospital routine practice, eligible for percutaneous coronary intervention using DES (and reference vessel diameter [RVD] matches available Nobori™ DES sizes)
3. Patient or the patients legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site, wherever such requirement exists
NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all patients complying with inclusion criteria. It is also desirable to have at least two cardiologists as investigators in each centre.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3000
Participant exclusion criteria
Exclusion criteria will be according to the instructions for the use of the device.
Recruitment start date
01/04/2008
Recruitment end date
30/11/2013
Locations
Countries of recruitment
Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Indonesia, Israel, Italy, Korea, South, Latvia, Macao, Malaysia, Morocco, Netherlands, New Zealand, Russian Federation, Serbia, Singapore, Slovenia, Sweden, Switzerland, Tunisia, Turkey, United Kingdom, Viet Nam
Trial participating centre
Research Park Zone 2 Haasrode
Leuven
B-3001
Belgium
Sponsor information
Organisation
Terumo Europe N.V. (Belgium)
Sponsor details
Research Park Zone 2 Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium
+32 (0)16 38 13 80
danny.detiege@terumo-europe.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Terumo Europe N.V. (Belgium) (ref: T109E2)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22278136
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28183306
Publication citations
-
Results
Danzi GB, Chevalier B, Urban P, Fath-Ordoubadi F, Carrie D, Wiemer M, Serra A, Wijns W, Kala P, Stabile A, Ruigomez JG, Sagic D, Laanmets P, Strupp G, West N, Paunovic D, , Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study., EuroIntervention, 2012, 8, 1, 109-116, doi: 10.4244/EIJV8I1A17.