An observational study in Coronary Artery Disease, sponsored by Terumo Europe N.V.. Completed at 257 sites in 32 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-09.
Sponsored by Terumo Europe N.V. (part of Terumo Corporation) · Observational
Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
Objective Primary objective The primary objective of e-NOBORI registry is to further validate the safety and efficacy of Nobori® DES system in unselected patients representing everyday clinical practice.
Primary Endpoint: Freedom from Target Lesion Failure (TLF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) at 1 year
Up to 200 centres across Europe, Asia and Central and South America
-Patient Population : \~18000 eligible patients suitable for treatment with the Nobori® DES will be entered in the e-NOBORI registry
Eligibility Criteria
NOTE: In order to avoid bias it is recommended that all investigators aim to enrol all consecutive patients complying with study eligibility criteria. It is also desirable to have at least two cardiologists as investigators in each centre.
According to pre-specified criteria, patients will be automatically allocated to one or more sub-studies as following:
NOBORI Diabetes
In addition to above mentioned sub-studies there will be geographic sub-studies for the main areas.
Medication Pre-Procedure: According to hospital routine practice Post-Procedure: Mandatory antiplatelet treatment, according to hospital routine practice (minimum 6 months DAT)
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 18,000 is above the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Terumo Europe N.V. is the lead sponsor of 25 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suitable for PCI intervention
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient admitted with stable angina
Patients admitted with Acute Coronary Syndrome
Participant female patients
One or more lesions treated during the baseline in bifurcation
Patients that were insulin-dependent diabetes mellitus at admission
Patients that were non-insulin-dependent diabetes mellitus at admission
vessels smaller or equal to 2.75mm
Lesions longer or equal to 20mm
Patients that at admission had renal insufficiency (\> 2.0 mg/dL - 176 µmol/mL) at admission
Patients more or equal 80 years old
One or more lesions treated during the baseline in were restenotic lesions
Patients who underwent the treatment of more than 1 vessel during the index procedure
Patients who underwent a PCI on the Left Main Trunk, on a Chronic Total Occluded lesion or located on a Saphenous Vein Graft
Total Population
FREEDOM OF TARGET LESION FAILURE
TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION
Time frame: 1 YEAR
Procedural success
Procedural success is defined as achievement of a diameter of stenosis of \<30% by visual assessment and/or \<50% by QCA, using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesión during the hospital stay.
Time frame: 1 MONTH
Device success
Device Success defined as attainment of a final residual diameter stenosis of the target lesion of \< 30% by visual assessment and/or \< 50% by QCA, using the assigned device only. Device Success defined as attainment of a final residual diameter stenosis of the target lesion of \< 30% by visual assessment and/or \< 50% by QCA, using the assigned device only. Device success is defined as attainment of a final residual diameter stenosis of the target lesión of \<30% by visual assessment and/or \>50% QCA, using the assigned device only.
Time frame: 1 MONTH
Acute/subacute stent thrombosis
(definite/probable according to ARC definitions)
Time frame: 1 MONTH
Peri-procedural myocardial infarction
Peri-procedural myocardial infarction
Time frame: 1 MONTH
Rate of Major Adverse Cardiac Events (MACE)
Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)
Time frame: 1 MONTH
Major vascular and bleeding complications
NOT CABG RELATED
Time frame: 1 MONTH
Cardiac death/ Myocardial Infarction
Cardiac death/ Myocardial Infarction
Time frame: 1 AND 2 YEARS
Clinically driven target lesion revascularization (TLR)
re-PCI or CABG involving target lesion
Time frame: 1 & 2 YEARS
Stent thrombosis
(definite/probable; ARC definition)
Time frame: 1 AND 2 YEARS
Clinically driven target vessel revascularization (TVR)
PCI AND CABG
Time frame: 1 AND 2 YEARS
Target Lesion Failure (TLF)
Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization
Time frame: 1 MONTH AND 2 YEARS
Patient Oriented Composite Endpoint defined as any cause of mortality, MI (Q-wave and non Q-wave), or any TVR
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
Composite Endpoint of Cardiac death and MI
Time frame: 1 MONTH, 1 AND 2 YEARS
Composite Endpoint of Cardiac death and post-procedural MI
Composite Endpoint of Cardiac death and post-procedural MI
Time frame: 1 month, 1 and 2 years post-procedure
Stent thrombosis
definite and probable according to ARC definitions
Time frame: 1 month, 1 and 2 years post-procedure
Primary Stent thrombosis
definite and probable according to ARC definitions
Time frame: 1 month, 1 and 2 years post-procedure
Secondary Stent thrombosis
definite and probable according to ARC definitions
Time frame: 1 month, 1 and 2 years post-procedure
Duration of dual antiplatelet therapy
Duration of dual antiplatelet therapy
Time frame: UP TO 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
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
Clinically driven Target Lesion Revascularization
Clinically driven Target Lesion Revascularization
Time frame: 1 MONTH
Clinically driven Target Vessel Revascularization
Clinically driven Target Vessel Revascularization
Time frame: 1 MONTH
Showing the first 100 of 257 sites across 32 countries. Choose a country and city above to see the rest.
Ran from Aug 2010 to primary completion in May 2016, 69 months.
Of 125 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 69 months is above that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.