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

Study Overview
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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.

Official Title
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Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure

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

Intervention / Treatment
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* Procedure: Percutaneous recanalization of chronic total occlusion


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Successfully CTO recanalization<br> | Procedure: Percutaneous recanalization of chronic total occlusion<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of uncovered stent struts | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number uncovered struts x 100)/total number of struts. | 3 months | 
| Percentage of malapposed stent struts | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. (Number of malapposed struts x 100)/total number of struts. | 3 months | 
| Percentage of neointimal hyperplasia proliferation | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. [(minimal stent area - minimal lumen area)/minimal stent area]x100. | 3 months | 
| Minimal lumen area | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. | 3 months | 
| Minimal lumen diameter | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted | 3 months | 
| Thrombus | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. | 3 months | 
| Edge dissection | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relevancy of immediate post-PCI OFDI analysis | To estimate the percentage of patients in whom the post-stenting OFDI analysis will reveal a suboptimal result of angioplasty whereas final angiography was considered optimal, as assessed by the presence of one or more of the following criteria: Dissection or thrombus. Residual stenosis. Stent malapposition defined by at least one malapposed strut. Residual stenosis. | Day one | 
| Impact of the technique employed for CTO revascularization on the reendothelialization | Comparison of primary composite endpoint between different way of recanalization: Anterograde. Retrograde. Dissection/re-entry. | 3 months | 
| One year clinical follow-up | Each participating center will perform one year after CTO PCI a clinical evaluation of all patients included. This could be established directly with the subject during medical follow-up or indirectly via family doctor. Standardized questionnaire will be provided at the end of the e-case report form (CRF). Occurrence of major adverse cardiac events (myocardial infarction, death, stroke), sudden death, hospitalization for cardiac disease and severe hemorrhage will be recorded. Any new coronary arteriography will be noticed, as well as any PCI or coronary artery bypass graft (CABG) during this one-year follow-up. Death all-cause Myocardial infarction Stroke Sudden death Hospitalization for cardiac cause Severe hemorrhage | One year | 
| Angina | About symptoms, the Canadian Cardiovascular Society (CCS) grading system and New York Heart Association functional classification will be used to assess respectively exertion-induced angina and dyspnea, and compared to symptoms recorded before CTO revascularization. | One year | 
| Dyspnea | About symptoms, the Canadian Cardiovascular Society (CCS) grading system and New York Heart Association functional classification will be used to assess respectively exertion-induced angina and dyspnea, and compared to symptoms recorded before CTO revascularization. | One year |