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

Poitiers University Hospital

Status

Completed

Conditions

Neointimal Hyperplasia

Optical Coherence Tomography

Chronic Total Occlusion of Coronary Artery

Stent Thrombosis

Ischemic Cardiomyopathy

Treatments

Procedure: Percutaneous recanalization of chronic total occlusion

Study type

Interventional

Funder types

Other

Identifiers

NCT03209843

PERFECTO

Details and patient eligibility

About

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.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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