Clinical trial NCT03209843: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
Official title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Optical Coherence Tomography
Ischemic Cardiomyopathy
Neointimal Hyperplasia
Stent Thrombosis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of uncovered stent struts
timeFrame: 3 months
measure: Percentage of malapposed stent struts
timeFrame: 3 months
measure: Percentage of neointimal hyperplasia proliferation
timeFrame: 3 months
measure: Minimal lumen area
timeFrame: 3 months
measure: Minimal lumen diameter
timeFrame: 3 months
measure: Thrombus
timeFrame: 3 months
measure: Edge dissection
timeFrame: 3 months
Secondary outcomes:
measure: Relevancy of immediate post-PCI OFDI analysis
timeFrame: Day one
measure: Impact of the technique employed for CTO revascularization on the reendothelialization
timeFrame: 3 months
measure: One year clinical follow-up
timeFrame: One year
measure: Angina
timeFrame: One year
measure: Dyspnea
timeFrame: One year
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: GHM de Grenoble
city: Nantes
country: France
facility: Bressollette
city: Nimes
country: France
facility: CHU de Nimes
city: Poitiers
country: France
facility: CHU Poitiers
city: Saint Laurent Du Var
country: France
facility: Institut A.Tzanck
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital of Poitiers, Department of Cardiology
name: Sebastien Levesque, MD
role: PRINCIPAL_INVESTIGATOR
References: