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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
122
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.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
GHM de Grenoble
Grenoble, France
Bressollette
Nantes, France
CHU de Nimes
Nîmes, France
CHU Poitiers
Poitiers, France
Institut A.Tzanck
Saint-Laurent-du-Var, France
CHU de Toulouse
Toulouse, France
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
Minimal lumen area
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Time frame: 3 months
Minimal lumen diameter
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
Time frame: 3 months
Thrombus
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Time frame: 3 months
Edge dissection
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Time frame: 3 months
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: 1. Dissection or thrombus. 2. Residual stenosis. 3. Stent malapposition defined by at least one malapposed strut. 4. Residual stenosis.
Time frame: Day one
Impact of the technique employed for CTO revascularization on the reendothelialization
Comparison of primary composite endpoint between different way of recanalization: 1. Anterograde. 2. Retrograde. 3. Dissection/re-entry.
Time frame: 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. 1. Death all-cause 2. Myocardial infarction 3. Stroke 4. Sudden death 5. Hospitalization for cardiac cause 6. Severe hemorrhage
Time frame: 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.
Time frame: 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.
Time frame: One year
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