Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

In-stent Restenosis Clinical Trial

— RESTO  

Official title:

Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04268875
• Other study ID #: RBHP 2019 SOUTEYRAND
• Secondary ID: 2019-A02305-52
• Status: Completed
• Phase: N/A
• Start date: December 11, 2019
• Est. completion date: December 6, 2022

Study information

• Verified date: April 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men or women, aged 18 years and over.

• Uncoated, coated or bioresorbable stent restenosis, defined by lumen obstruction of over 50% in the stent and/or within 5 mm proximal or distal to the stent found on coronary angiography.

• Patients treated for an acute coronary syndrome in which restenosis is suspected. It is recommended that OCT be performed after restoring TIMI grade 3 coronary flow in the initial investigation or in a later review at < 7 days.

• Patient informed consent.

• Subscription to a social security system.

Exclusion Criteria:

• Technical inability to perform the OCT (distal lesions, severe chronic renal failure).

• Contraindication to the use of ABBOTT systems when insertion of any type of catheter represents a risk to the patient. The contraindications include the following:

• Bacteraemia or septicaemia

• Significant coagulation system abnormalities

• Patients in whom coronary artery spasm has been diagnosed

• Patients who do not meet the criteria for coronary artery bypass grafting

• Patients who do not meet the criteria for percutaneous coronary angioplasty

• Severe haemodynamic shock or instability

• Total occlusion

• Life expectancy of under one year for non-cardiac reasons.

• Pregnant or breast-feeding women or women who are fertile and not taking appropriate contraceptives.

• Patients under legal protection or guardianship

Related Conditions & MeSH terms

• In-stent Restenosis

Intervention

Device:
• Optical Coherence Tomography (OCT)
The OCT fibre is an optical fibre catheter containing a lens located at its extremity and positioned distal to the arterial segment to be examined. This is an intracoronary, very high-resolution section technique based on absorption and reflection of close infrared light by stents and tissues. OCT analysis is performed during a usual coronary angiography procedure. It is a common technique already used and recommended for intrastent restenosis to establish the mechanism of the process. No new product is being tested. The examination performed is the same.

Locations

Country	Name	City	State
Belgium	Université- Hôpital Leuven	Leuven
France	Clinique la Roseraie	Aubervilliers
France	CH Avignon	Avignon
France	CHRU Besançon	Besançon
France	CHU Bordeaux	Bordeaux
France	CHRU Morvan	Brest
France	Hôpital privé saint Martin	Cauro
France	Centre Hospitalier les Hôpitaux de Chartres	Chartres
France	CHU Clermont Ferrand	Clermont-Ferrand	Auvergne
France	CHRU Grenoble Alpes	Grenoble
France	Centre Hospitalier Départemental Vendée	La Roche-sur-Yon
France	CHRU Lille	Lille
France	Centre Hospitalier Saint Joseph Saint Luc	Lyon
France	Hospices Civiles Lyon	Lyon
France	AP-HM	Marseille
France	CHRU Nîmes	Nîmes
France	Polyclinique les fleurs	Ollioules
France	AP-HP	Paris
France	Hôpital Privé Institut Mutualiste Montsouris	Paris
France	CHRU Poitiers	Poitiers
France	Clinique Saint Hilaire	Rouen
France	CHRU Strasbourg	Strasbourg
France	Clinique Pasteur Toulouse	Toucy
France	CHRU Toulouse	Toulouse
France	CHRU Hôpitaux de Tours	Tours
Switzerland	CH de Bern	Bern
Switzerland	CHUV de Lausanne	Lausanne

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Abbott, Corelab ISIT

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis	Under-deployment of the stent with percentage under-deployment is defined when the minimum intrastent surface area is less than 80% of the reference surface area.	day 0
Primary	Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis	Homogeneous or non-homogeneous intimal hyperplasia.	day 0
Primary	Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis	Presence of neoatherosclerosis, with or without rupture.	day 0
Primary	Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis	Stent fracture .	day 0
Primary	Characteristics of morphological abnormalities, seen on OCT on millimetre sections of the whole stented segment (5 mm proximally and distally to the stent), potentially responsible for the intrastent restenosis	Progression of the proximal or distal atherosclerosis .	day 0
Secondary	Clinical data	time to onset of intrastent restenosis	day 0
Secondary	Clinical data	sex	day 0
Secondary	Clinical data	age	day 0
Secondary	Clinical data	past history of angioplasty	day 0
Secondary	Clinical data	myocardial infarction	day 0
Secondary	Clinical data	coronary artery bypass grafting	day 0
Secondary	Clinical data	multi-vessel disease	day 0
Secondary	Clinical data	prosthetic valve	day 0
Secondary	Clinical data	heart failure	day 0
Secondary	Clinical data	chronic renal failure	day 0
Secondary	Clinical data	atrial fibrillation	day 0
Secondary	Clinical data	valve disease	day 0
Secondary	Clinical data	vascular disease	day 0
Secondary	Clinical data	CVA	day 0
Secondary	Clinical data	TIA	day 0
Secondary	Cardiovascular risk factors	hypertension	day 0
Secondary	Cardiovascular risk factors	dyslipidaemia	day 0
Secondary	Cardiovascular risk factors	diabetes	day 0
Secondary	Cardiovascular risk factors	family history	day 0
Secondary	Cardiovascular risk factors	overweight (BMI > 25)	day 0
Secondary	Cardiovascular risk factors	smoking habit	day 0
Secondary	Blood sample	Measure of LDL cholesterol	day 0, day 365
Secondary	Blood sample	Measure of HDL cholesterol	day 0, day 365
Secondary	Blood sample	Measure of triglycerides	day 0, day 365
Secondary	Blood sample	Measure of HbA1c	day 0, day 365
Secondary	Blood sample	Measure of creatinine	day 0, day 365
Secondary	Blood sample	Measure of renal clearance	day 0, day 365
Secondary	New revascularisation events	new revascularisation event in the target lesion or another artery, myocardial infarctions, deaths and causes of events	day 365