e-NOBORI Observational Registry of Nobori DES

This study is currently recruiting participants.
Verified December 2012 by Terumo Europe N.V.
Sponsor:
Information provided by (Responsible Party):
Terumo Europe N.V.
ClinicalTrials.gov Identifier:
NCT01261273
First received: December 14, 2010
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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


Condition
Percutaneous Coronary Intervention

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Prospective, Single-Arm, Multi-Centre, Observational Registry to Further Validate Safety and Efficacy of the Nobori DES in Real-World Patients

Resource links provided by NLM:


Further study details as provided by Terumo Europe N.V.:

Primary Outcome Measures:
  • FREEDOM OF TARGET LESION FAILURE [ Time Frame: 1 YEAR ] [ Designated as safety issue: Yes ]
    TLF: COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION AND TARGET LESION REVASCULARIZATION


Secondary Outcome Measures:
  • Procedural success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Device success [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
  • Acute/subacute stent thrombosis [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    (definite/probable according to ARC definitions)

  • Peri-procedural myocardial infarction [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Rate of Major Adverse Cardiac Events (MACE) [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
    Major Adverse Cardiac Events (MACE) defined as a composite of cardiac death, MI or clinically driven target vessel revascularization (TVR)

  • Major vascular and bleeding complications [ Time Frame: 1 MONTH ] [ Designated as safety issue: No ]
    NOT CABG RELATED

  • Cardiac death/ Myocardial Infarction [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Clinically driven target lesion revascularization (TLR) [ Time Frame: 1 & 2 YEARS ] [ Designated as safety issue: Yes ]
    re-PCI or CABG involving target lesion

  • Stent thrombosis [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    (definite/probable; ARC definition)

  • Clinically driven target vessel revascularization (TVR) [ Time Frame: 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
    PCI AND CABG

  • Target Lesion Failure (TLF) [ Time Frame: 1 MONTH AND 2 YEARS ] [ Designated as safety issue: Yes ]
    Defined as a composite of cardiac death, target vessel related myocardial infarction (MI) and clinically driven target lesion revascularization

  • 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 ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and MI [ Time Frame: 1 MONTH, 1 AND 2 YEARS ] [ Designated as safety issue: Yes ]
  • Composite Endpoint of Cardiac death and post-procedural MI [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Primary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Secondary Stent thrombosis [ Time Frame: 1 month, 1 and 2 years post-procedure ] [ Designated as safety issue: Yes ]
    definite and probable according to ARC definitions

  • Duration of dual antiplatelet therapy [ Time Frame: UP TO 2 YEARS ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Lesion Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]
  • Clinically driven Target Vessel Revascularization [ Time Frame: 1 MONTH ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8000
Study Start Date: August 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable angina
Acute Coronary Syndrome
Female
Bifurcation
Insulin Dependent Diabetes Mellitus
Non-Insulin Dependent Diabetes Mellitus
Small Vessels
vessels smaller or equal to 2.75mm
NOBORI Long Lesions
Lesions longer or equal to 20mm
Renal Insufficiency
Elderly
Patients more or equal 80 years old
Restenosis
Multivessel Treatment
Complex Lesions
Overall

Detailed 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 : ~8000 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suitable for PCI intervention

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261273

Contacts
Contact: Dragica Paunovic, Dr dragica.paunovic@terumo-europe.com

  Show 81 Study Locations
Sponsors and Collaborators
Terumo Europe N.V.
Investigators
Study Chair: Dragica Paunovic, Dr. Terumo Europe
  More Information

Publications:
Grube E, Spirit V registry: one-year follow-up. EuroIntervention 2009; 5
Safian R.D. and Freed M., Complications. In: The Manual of Interventional Cardiology Jones & Bartlett Publishers, 2001. 381-467
Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of left main coronary artery disease with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Oral Contributions Georgia World Congress Center, Room B315 Monday, March 15, 2010, 2:00 p.m.-2:12 p.m.). J Am Coll Cardiol 2010;55
Nakamura S, Nakamura S, Ogawa H, Bae JH, HansCahyadi Y, Udayachalerm W, DTresukosol D, Tansuphaswadikul S, Drug-eluting stents for the treatment of chronic total occlusion: a comparison with sirolimus, paclitaxel, zotarolimus, BiolimusA9, EPC capture and everolimus-eluting stent: multicenter registry in Asia (Poster Contributions Georgia World Congress Center, Hall B5 Monday, March 15, 2010, 9:30 a.m.-10:30 a.m. ). J Am Coll Cardiol 2010;55.

Responsible Party: Terumo Europe N.V.
ClinicalTrials.gov Identifier: NCT01261273     History of Changes
Other Study ID Numbers: T113E2
Study First Received: December 14, 2010
Last Updated: December 6, 2012
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by Terumo Europe N.V.:
PCI
observational registry

ClinicalTrials.gov processed this record on April 17, 2014