e-NOBORI Observational Registry of Nobori DES

Terumo

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01261273

T113E2

Details and patient eligibility

About

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

Full description

• Title Prospective, single-arm, multi-centre, observational registry to further validate safety and efficacy of the Nobori® DES in real-world patients.
• 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
• Clinical Site Locations:

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

• 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.

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 Acute Coronary Syndrome

• NOBORI Stable angina

• NOBORI Female

• NOBORI Bifurcation

• NOBORI Diabetes

  • Insulin Dependent Diabetes Mellitus (IDDM)
  • Non-Insulin Dependent Diabetes Mellitus (NIDDM)

• NOBORI Small Vessels (less or equal 2.75mm)

• NOBORI Long Lesions (more or equal 20mm)

• NOBORI Renal Insufficiency (> 2.0 mg/dL - 176 µmol/mL)

• NOBORI Elderly (more or equal 80 years of age)

• NOBORI Restenosis

• NOBORI Multivessel Treatment

• NOBORI Complex Lesions

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)

Enrollment: 18,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

18,000 participants in 14 patient groups

Stable angina

Description:

Patient admitted with stable angina

Acute Coronary Syndrome

Description:

Patients admitted with Acute Coronary Syndrome

Female

Description:

Participant female patients

Bifurcation

Description:

One or more lesions treated during the baseline in bifurcation

Insulin Dependent Diabetes Mellitus

Description:

Patients that were insulin-dependent diabetes mellitus at admission

Non-Insulin Dependent Diabetes Mellitus

Description:

Patients that were non-insulin-dependent diabetes mellitus at admission

Small Vessels

Description:

vessels smaller or equal to 2.75mm

NOBORI Long Lesions

Description:

Lesions longer or equal to 20mm

Renal Insufficiency

Description:

Patients that at admission had renal insufficiency (\> 2.0 mg/dL - 176 µmol/mL) at admission

Elderly

Description:

Patients more or equal 80 years old

Restenosis

Description:

One or more lesions treated during the baseline in were restenotic lesions

Multivessel Treatment

Description:

Patients who underwent the treatment of more than 1 vessel during the index procedure

Complex Lesions

Description:

Patients who underwent a PCI on the Left Main Trunk, on a Chronic Total Occluded lesion or located on a Saphenous Vein Graft

Overall

Description:

Total Population