Ignite Creation Date:
2024-05-05 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00774917
Status:
UNKNOWN
Last Update Posted:
2009-06-23
First Post:
2008-10-16
Brief Title:
Numen Stent Assessment Using OCT Technique in a Single Center Study
Sponsor:
International Biomedical Systems SpA
Organization:
International Biomedical Systems SpA
Study Overview
Official Title:
Numen Stent Assessment Using OCT Technique in a Single Center Study
Status:
UNKNOWN
Status Verified Date:
2009-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NAUTIC
Brief Summary:
This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS except STEMI
A total of 60 consecutive patients will be enrolled in the study Patients with de novo native coronary artery lesions 10mm and 24mm in length and 250mm to 350mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation After stent deployment an OCT imaging will be performed within the treated segment Patients will be followed at 30 days 6 months and 12 months post-procedure with all patients having repeat angiography and OCT at 6 months
It is anticipated that the total length of the study will be 18 months 6 months to complete patient enrolment and 12 months for follow-up
A total of 60 consecutive patients will be enrolled in the study Patients with de novo native coronary artery lesions 10mm and 24mm in length and 250mm to 350mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation After stent deployment an OCT imaging will be performed within the treated segment Patients will be followed at 30 days 6 months and 12 months post-procedure with all patients having repeat angiography and OCT at 6 months
It is anticipated that the total length of the study will be 18 months 6 months to complete patient enrolment and 12 months for follow-up
Detailed Description:
OBJECTIVES
The main objective of this study is to assess the long term influence of NUMEN cobalt-chromium balloon-expandable coronary stent on neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or Acute Coronary Syndrom ACS - except STEMI
ENDPOINTS
The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up
Breakdown of secondary endpoints
Degree of endothelialization of the stent internal wall by OCT at 6 months after stent implantation Composite of Major Adverse Cardiac Events MACE defined as cardiac death non-fatal myocardial infarction MI Q wave and non-Q wave emergent bypass surgery stent thrombosis or repeat target lesion revascularization at 30 days 6 months and 12 months post-procedure
Angiographic binary restenosis 50 diameter stenosis 6 months post-procedure
Target vessel failure at 6 months post-procedure Device success defined as achievement of a final residual diameter stenosis of 30 by Quantitative Coronary Angiography QCA using the assigned device only If QCA is not available the visual estimate of diameter stenosis is used
Lesion success defined as the attainment of 30 residual stenosis by QCA using any percutaneous method
Procedure success defined as achievement of a final diameter stenosis of 30 by QCA using any percutaneous method without the occurrence of death MI or repeat revascularization of the target lesion during the hospital stay
Acute 24 hrs post procedure subacute up to 30days post procedure and late 30days post procedure thrombosis
OVERVIEW OF THE STUDY
This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS except STEMI
A total of 60 consecutive patients will be enrolled in the study Patients with de novo native coronary artery lesions 10mm and 24mm in length and 250mm to 350mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation After stent deployment an OCT imaging will be performed within the treated segment Patients will be followed at 30 days 6 months and 12 months post-procedure with all patients having repeat angiography and OCT at 6 months
It is anticipated that the total length of the study will be 18 months 6 months to complete patient enrolment and 12 months for follow-up
The main objective of this study is to assess the long term influence of NUMEN cobalt-chromium balloon-expandable coronary stent on neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or Acute Coronary Syndrom ACS - except STEMI
ENDPOINTS
The primary endpoint is the assessment of the development of neointimal hyperplasia by OCT in the stented segment at 6-month follow-up
Breakdown of secondary endpoints
Degree of endothelialization of the stent internal wall by OCT at 6 months after stent implantation Composite of Major Adverse Cardiac Events MACE defined as cardiac death non-fatal myocardial infarction MI Q wave and non-Q wave emergent bypass surgery stent thrombosis or repeat target lesion revascularization at 30 days 6 months and 12 months post-procedure
Angiographic binary restenosis 50 diameter stenosis 6 months post-procedure
Target vessel failure at 6 months post-procedure Device success defined as achievement of a final residual diameter stenosis of 30 by Quantitative Coronary Angiography QCA using the assigned device only If QCA is not available the visual estimate of diameter stenosis is used
Lesion success defined as the attainment of 30 residual stenosis by QCA using any percutaneous method
Procedure success defined as achievement of a final diameter stenosis of 30 by QCA using any percutaneous method without the occurrence of death MI or repeat revascularization of the target lesion during the hospital stay
Acute 24 hrs post procedure subacute up to 30days post procedure and late 30days post procedure thrombosis
OVERVIEW OF THE STUDY
This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions of patients with Stable Angina Pectoris or ACS except STEMI
A total of 60 consecutive patients will be enrolled in the study Patients with de novo native coronary artery lesions 10mm and 24mm in length and 250mm to 350mm in diameter by QCA estimate who meet all eligibility criteria will be enrolled and undergone stent implantation After stent deployment an OCT imaging will be performed within the treated segment Patients will be followed at 30 days 6 months and 12 months post-procedure with all patients having repeat angiography and OCT at 6 months
It is anticipated that the total length of the study will be 18 months 6 months to complete patient enrolment and 12 months for follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None