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

NCT04268875 | Completed

• 2 other identifiers: RBHP 2019 SOUTEYRAND2019-A02305-52
• Study Type: interventional
• Target: 307
• Locations: 3 countries
• Sites: 27

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.

Conditions

In-stent Restenosis

Keywords

In-stent restenosis; optical coherence tomography (OCT); coronary angiography

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (28)

• Clinical data

  day 0

• Clinical data

  day 0

• Clinical data

  day 0

• Clinical data

  day 0

• Clinical data

  day 0

Study Arms (1)

OCT

EXPERIMENTAL

Patient witch coronary artery disease who has been stented and is hospitalised for stable angina or acute coronary syndrome requiring a further coronary angiogram (regardless of time since implantation or type of the initial stent. \- Identification of intrastent restenosis during coronary angiography and realisation of an immediate or deferred OCT.

Device: Optical Coherence Tomography (OCT)

Interventions

Optical Coherence Tomography (OCT) DEVICE

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.

OCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Abbott: collaborator
• Corelab ISIT: collaborator

Study Sites (27)

Université- Hôpital Leuven

Leuven, Belgium

Location

CHU Clermont Ferrand

Clermont-Ferrand, Auvergne, 63000, France

Location

Clinique la Roseraie

Aubervilliers, France

Location

CH Avignon

Avignon, France

Location

CHRU Besançon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHRU Morvan

Brest, France

Location

Hôpital privé saint Martin

Cauro, France

Location

Centre Hospitalier les Hôpitaux de Chartres

Chartres, France

Location

CHRU Grenoble Alpes

Grenoble, France

Location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Location

CHRU Lille

Lille, France

Location

Centre Hospitalier Saint Joseph Saint Luc

Lyon, France

Location

Hospices Civiles Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

CHRU Nîmes

Nîmes, France

Location

Polyclinique les fleurs

Ollioules, France

Location

AP-HP

Paris, France

Location

Hôpital Privé Institut Mutualiste Montsouris

Paris, France

Location

CHRU Poitiers

Poitiers, France

Location

Clinique Saint Hilaire

Rouen, France

Location

CHRU Strasbourg

Strasbourg, France

Location

Clinique Pasteur Toulouse

Toucy, France

Location

CHRU Toulouse

Toulouse, France

Location

CHRU Hôpitaux de Tours

Tours, France

Location

CH de Bern

Bern, Switzerland

Location

CHUV de Lausanne

Lausanne, Switzerland

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Géraud Souteyrand

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 13, 2020
• Study Start: December 11, 2019
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CH (2); FR (24); BE (1)