e-NOBORI Observational Registry of Nobori DES

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01261273
• Date of registration: 14/12/2010
• Prospective Registration: No
• Primary sponsor: Terumo Europe N.V.
• Public title: e-NOBORI Observational Registry of Nobori DES e-NOBORI
• Scientific title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients
• Date of first enrolment: August 25, 2010
• Target sample size: 18000
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01261273
• Study type: Observational

Countries of recruitment

Austria, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Chile, Czech Republic, Czechia, Denmark, Egypt, Estonia, France, Georgia, Germany, Hungary, Indonesia, Ireland, Israel, Latvia, Lithuania, Malta, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovenia, Spain, Sweden, Taiwan, Ukraine, United Kingdom

Contacts

• Name: Dragica Paunovic, Dr.
• Affiliation: Terumo Europe

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient is more or equal 18 years old;

- Patient is, according to hospital routine practice, eligible for percutaneous coronary
intervention using DES (and RVD matches available Nobori® DES sizes);

- Patient has been informed of the nature of the study and agrees to its provisions, has
provided written informed consent as approved by the Institutional Review Board/Ethics
Committee of the respective clinical site, wherever such requirement exists.

Exclusion Criteria:

- None



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Primary Outcome(s)

FREEDOM OF TARGET LESION FAILURE [Time Frame: 1 YEAR]

Secondary Outcome(s)

Cardiac death/ Myocardial Infarction [Time Frame: 1 AND 2 YEARS]

Major vascular and bleeding complications [Time Frame: 1 MONTH]

Secondary Stent thrombosis [Time Frame: 1 month, 1 and 2 years post-procedure]

Clinically driven target vessel revascularization (TVR) [Time Frame: 1 AND 2 YEARS]

Stent thrombosis [Time Frame: 1 AND 2 YEARS]

Composite Endpoint of Cardiac death, post-procedural MI and stent thrombosis rate during the course of DAT versus the same events after cessation of DAT [Time Frame: UP TO 2 YEARS]

Device success [Time Frame: 1 MONTH]

Primary Stent thrombosis [Time Frame: 1 month, 1 and 2 years post-procedure]

Duration of dual antiplatelet therapy [Time Frame: UP TO 2 YEARS]

Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR [Time Frame: 1 MONTH, 1 AND 2 YEARS]

Composite Endpoint of Cardiac death and MI [Time Frame: 1 MONTH, 1 AND 2 YEARS]

Peri-procedural myocardial infarction [Time Frame: 1 MONTH]

Acute/subacute stent thrombosis [Time Frame: 1 MONTH]

Clinically driven Target Lesion Revascularization [Time Frame: 1 MONTH]

Rate of Major Adverse Cardiac Events (MACE) [Time Frame: 1 MONTH]

Composite Endpoint of Cardiac death and post-procedural MI [Time Frame: 1 month, 1 and 2 years post-procedure]

Procedural success [Time Frame: 1 MONTH]

Clinically driven target lesion revascularization (TLR) [Time Frame: 1 & 2 YEARS]

Clinically driven Target Vessel Revascularization [Time Frame: 1 MONTH]

Stent thrombosis [Time Frame: 1 month, 1 and 2 years post-procedure]

Target Lesion Failure (TLF) [Time Frame: 1 MONTH AND 2 YEARS]

Secondary ID(s)

T113E2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors