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

Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure

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.

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