Condition category
Circulatory System
Date applied
08/05/2008
Date assigned
05/06/2008
Last edited
11/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Ethics approval received from:
1. Freiburger ethik kommission (Germany) on the 17th March 2008
2. Ziekenhuis Oost Limburg and Onze Lieve Voruw Ziekenhuis Aalst (Belgium) on the 29th April 2008
3. Bad Oeynhausen (Germany) on the 28th April 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-section survey

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Drug

Phase

Not Specified

Drug names

Nobori™ drug eluting stent

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 patient’s 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

http://www.terumo-europe.com/

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22278136

Publication citations

  1. 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.

Additional files

Editorial Notes