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Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)

NCT03209843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-04-14

No results posted yet for this study

Summary

The objective of PERFECTO is to assess the reendothelialization at 3 months after successfully CTO percutaneous intervention (PCI) with new generation drug eluting stent (DES) by OFDI analysis. Designed as a multicentric, observational and prospective study which will be conducted at University Hospital of Poitiers (France), a systematic OFDI analysis will be realized immediately after CTO-PCI and at 3 months. Known as major predictive factors of stent thrombosis, percentages of malapposition, uncovered struts and neointimal hyperplasia proliferation will be measured over the entire length of each stent implanted combining in a composite primary endpoint.

Conditions

  • Chronic Total Occlusion of Coronary Artery
  • Optical Coherence Tomography
  • Ischemic Cardiomyopathy
  • Neointimal Hyperplasia
  • Stent Thrombosis

Interventions

PROCEDURE

Percutaneous recanalization of chronic total occlusion

Percutaneous recanalization of chronic total occlusion followed by immediate systematic coronary optical frequency domain imaging (OFDI) at inclusion. Intra-individual post stenting assessment of reendothelialization with a second coronary angiography with OFDI analysis at 3 months.

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Principal Investigators

  • Sebastien Levesque, MD · University Hospital of Poitiers, Department of Cardiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2021-02-12
Completion
2021-02-12

Countries

  • France

Study Locations

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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 NCT03209843 on ClinicalTrials.gov