Clinical trial NCT04268875: Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT
Official title: Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: In-stent Restenosis
Keywords: In-stent restenosis
optical coherence tomography (OCT)
coronary angiography
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Abbott
name: Corelab ISIT
First posted: 2020-02-13
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: day 0
measure: 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
timeFrame: day 0
measure: 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
timeFrame: day 0
measure: 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
timeFrame: day 0
measure: 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
timeFrame: day 0
Secondary outcomes:
measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Clinical data
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measure: Cardiovascular risk factors
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measure: Cardiovascular risk factors
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measure: Cardiovascular risk factors
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measure: Cardiovascular risk factors
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measure: Cardiovascular risk factors
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measure: Cardiovascular risk factors
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measure: Blood sample
timeFrame: day 0, day 365
measure: Blood sample
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measure: Blood sample
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measure: Blood sample
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measure: Blood sample
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measure: New revascularisation events
timeFrame: day 365
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Université- Hôpital Leuven
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
state: Auvergne
city: Aubervilliers
country: France
facility: Clinique la Roseraie
city: Avignon
country: France
facility: CH Avignon
city: Besançon
country: France
facility: CHRU Besançon
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHRU Morvan
city: Cauro
country: France
facility: Hôpital privé saint Martin
city: Chartres
country: France
facility: Centre Hospitalier les Hôpitaux de Chartres
city: Grenoble
country: France
facility: CHRU Grenoble Alpes
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Centre Hospitalier Saint Joseph Saint Luc
city: Lyon
country: France
facility: Hospices Civiles Lyon
city: Marseille
country: France
facility: AP-HM
city: Nîmes
country: France
facility: CHRU Nîmes
city: Ollioules
country: France
facility: Polyclinique les fleurs
city: Paris
country: France
facility: AP-HP
city: Paris
country: France
facility: Hôpital Privé Institut Mutualiste Montsouris
city: Poitiers
country: France
facility: CHRU Poitiers
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Strasbourg
country: France
facility: CHRU Strasbourg
city: Toucy
country: France
facility: Clinique Pasteur Toulouse
city: Toulouse
country: France
facility: CHRU Toulouse
city: Tours
country: France
facility: CHRU Hôpitaux de Tours
city: Bern
country: Switzerland
facility: CH de Bern
city: Lausanne
country: Switzerland
facility: CHUV de Lausanne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Géraud Souteyrand
role: PRINCIPAL_INVESTIGATOR
References: