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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-07

Study Completion Date

2021-02-12

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Successfully CTO recanalization

Group Type OTHER

Percutaneous recanalization of chronic total occlusion

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Successfully CTO revascularization by PCI with immediate post-PCI OFDI analysis
* 3 months follow-up with OFDI analysis of the recanalized coronary artery
* Aged 18 or over
* Written informed consent

Exclusion Criteria

* Contraindication or impossibility to realize a safety coronary OFDI (severe tortuosities)
* Severe renal insufficiency (creatinine clearance \< 30 ml/min)
* Pregnancy or women with child-bearing potential
* Bacteriemia or septicemia
* Severe hemodynamic instability
* Severe coagulation disorders

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No