Nobori 2 study to confirm the efficacy and safety of the CE marked Nobori stent in routine use

ISRCTN	ISRCTN81649913
DOI	https://doi.org/10.1186/ISRCTN81649913
Secondary identifying numbers	T109E2

Submission date: 08/05/2008
Registration date: 05/06/2008
Last edited: 13/02/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Danny Detiege
Scientific

Research Park Zone 2 Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium

Phone	+32 (0)16 38 13 80
Email	danny.detiege@terumo-europe.com

Study information

Study design	Observational single-arm prospective multi-centre study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	NOBORI 2: a prospective, multi-centre, observational study of the Nobori™ drug eluting stent system
Study acronym	NOBORI 2
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/04/2008
Completion date	30/11/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	3000
Key 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.
Key exclusion criteria	Exclusion criteria will be according to the instructions for the use of the device.
Date of first enrolment	01/04/2008
Date of final enrolment	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
Türkiye
United Kingdom
Viet Nam

Study participating centre

Research Park Zone 2 Haasrode

Leuven
B-3001
Belgium

Sponsor information

Terumo Europe N.V. (Belgium)
Industry

Research Park Zone 2 Haasrode
Interleuvenlaan 40
Leuven
B-3001
Belgium

Phone	+32 (0)16 38 13 80
Email	danny.detiege@terumo-europe.com
Website	http://www.terumo-europe.com/
"ROR"	https://ror.org/043vk3t22

Funders

Funder type

Industry

Terumo Europe N.V. (Belgium) (ref: T109E2)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/05/2012		Yes	No
Results article	results	10/02/2017		Yes	No

Editorial Notes

13/02/2017: Publication reference added.