Chronic Total Occlusion of Coronary Artery, Ischemic Cardiomyopathy, Neointimal Hyperplasia, Optical Coherence Tomography, Stent Thrombosis
Conditions
Brief 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.
Interventions
PROCEDUREPercutaneous 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
Poitiers University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Edge dissection | 3 months | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. |
| Percentage of uncovered stent struts | 3 months | 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. |
| Percentage of malapposed stent struts | 3 months | 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. |
| Percentage of neointimal hyperplasia proliferation | 3 months | 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. |
| Minimal lumen diameter | 3 months | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted |
| Thrombus | 3 months | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. |
| Minimal lumen area | 3 months | Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of the technique employed for CTO revascularization on the reendothelialization | 3 months | Comparison of primary composite endpoint between different way of recanalization: 1. Anterograde. 2. Retrograde. 3. Dissection/re-entry. |
| One year clinical follow-up | One year | 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 |
| Angina | One year | 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. |
| Dyspnea | One year | 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. |
| Relevancy of immediate post-PCI OFDI analysis | Day one | 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. |
Countries
France
Outcome results
None listed