Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04268875
Status:
COMPLETED
Last Update Posted:
2023-04-18
First Post:
2020-02-10
Brief Title:
Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
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:
RESTO
Brief Summary:
The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents drug-eluting stents DES The number and clinical lifespan of stents implanted over the last twenty-five years however explain the fact that restenosis remains a not unusual clinical problem which is expressed as a recurrence of angina or of an acute coronary syndrome ACS
The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred In symptomatic stent restenosis angina or acute coronary syndrome a further angioplasty is usually required occasionally on an emergency basis Coronary angiography is often not capable of explaining the mechanical causes of this complication
Optical coherence tomography OCT a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment OCT during angiography provides a detailed analysis of the stents and potential complications the presence of neoatherosclerosis with or without plaque rupture intimal hyperplasia stent under-deployment stent fracture and distal or proximal progression of the atherosclerosis
The investigators propose a prospective multicentre study of all cases of intrastent restenosis examined by angiography causing clinical features involving stable angina and acute coronary syndrome The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment There are several possible treatments for restenosis including balloon angioplasty coated balloon angioplasty stenting or aorto-coronary bypass graft surgery
The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred In symptomatic stent restenosis angina or acute coronary syndrome a further angioplasty is usually required occasionally on an emergency basis Coronary angiography is often not capable of explaining the mechanical causes of this complication
Optical coherence tomography OCT a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment OCT during angiography provides a detailed analysis of the stents and potential complications the presence of neoatherosclerosis with or without plaque rupture intimal hyperplasia stent under-deployment stent fracture and distal or proximal progression of the atherosclerosis
The investigators propose a prospective multicentre study of all cases of intrastent restenosis examined by angiography causing clinical features involving stable angina and acute coronary syndrome The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment There are several possible treatments for restenosis including balloon angioplasty coated balloon angioplasty stenting or aorto-coronary bypass graft surgery
Detailed Description:
All stented coronary artery patients hospitalised for stable angina or an ACS requiring a further coronary angiogram regardless of time since implantation or type of the initial stent identified to have intrastent restenosis during coronary angiography will be included after being informed and obtaining their informed written consent
For cases of stable angina the OCT the will be performed immediately with insertion of the probe distal to the area being studied and then automatic retraction of the fibre during injection of the contrast medium
For ACS the OCT will be performed immediately or on a deferred basis at the discretion of the operator
For critical lesions which prevent the OCT fibre passing across the lesion soft predilatation with a 2 mm or smaller balloon is permitted
Practical conduct of the OCT
Pullback at baseline state and analysis of the stent with a 5 mm margin proximal and distal to the lesion
OCT analysis under-deployment of the stent expansion 80 of the reference mean surface area neoatherosclerosis with or without rupture homogeneous or non-homogeneous hyperplasia stent fracture and proximal or distal progression of the atherosclerosis
Final pullback in cases of a new angioplasty balloon angioplasty angioplasty with a coated balloon or stenting
The OCT investigations will be anonymised and registered in their original format with a view to centralised reading Corelab ISIT UMR 6284-CNRS Clermont-Ferrand University
The angiography records will be submitted for reading by a panel blinded to the OCT for the purposes of demonstrating the added value of OCT in the fine details of diagnosis and the impact of a treatment decision The angiograms will be reviewed in a centralised analytical laboratory which will re-read the procedures blind
Patients will be followed up via telephone contact or visit one year after inclusion into the study to record any complications which have developed possible myocardial infarction reason any new revascularisation of the target lesion or another artery and reason for this any deaths and their causes
For cases of stable angina the OCT the will be performed immediately with insertion of the probe distal to the area being studied and then automatic retraction of the fibre during injection of the contrast medium
For ACS the OCT will be performed immediately or on a deferred basis at the discretion of the operator
For critical lesions which prevent the OCT fibre passing across the lesion soft predilatation with a 2 mm or smaller balloon is permitted
Practical conduct of the OCT
Pullback at baseline state and analysis of the stent with a 5 mm margin proximal and distal to the lesion
OCT analysis under-deployment of the stent expansion 80 of the reference mean surface area neoatherosclerosis with or without rupture homogeneous or non-homogeneous hyperplasia stent fracture and proximal or distal progression of the atherosclerosis
Final pullback in cases of a new angioplasty balloon angioplasty angioplasty with a coated balloon or stenting
The OCT investigations will be anonymised and registered in their original format with a view to centralised reading Corelab ISIT UMR 6284-CNRS Clermont-Ferrand University
The angiography records will be submitted for reading by a panel blinded to the OCT for the purposes of demonstrating the added value of OCT in the fine details of diagnosis and the impact of a treatment decision The angiograms will be reviewed in a centralised analytical laboratory which will re-read the procedures blind
Patients will be followed up via telephone contact or visit one year after inclusion into the study to record any complications which have developed possible myocardial infarction reason any new revascularisation of the target lesion or another artery and reason for this any deaths and their causes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-A02305-52 | OTHER | 2019-A02305-52 | None |