MedTrace Logo

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

NCT04268875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Corelab ISIT

    collaborator UNKNOWN

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Géraud Souteyrand · University Hospital, Clermont-Ferrand

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2022-12-06
Completion
2022-12-06

Countries

  • Belgium
  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04268875 on ClinicalTrials.gov