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

Not Applicable

Completed

• Conditions: Chronic Total Occlusion of Coronary Artery; Neointimal Hyperplasia; Stent Thrombosis; Optical Coherence Tomography; Ischemic Cardiomyopathy
• Interventions: Procedure: Percutaneous recanalization of chronic total occlusion

• Registration Number: NCT03209843
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Study Start: 2018-03-07
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Successfully CTO recanalization	Percutaneous recanalization of chronic total occlusion	-

Primary Outcome Measures

Name	Time	Method
Minimal lumen diameter	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.
Thrombus	3 months	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
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.
Minimal lumen area	3 months	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
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.
Edge dissection	3 months	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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

Trial Locations

Locations (7)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

Bressollette; 🇫🇷 Nantes, France

GHM de Grenoble; 🇫🇷 Grenoble, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHU de Nimes; 🇫🇷 Nimes, France

Institut A.Tzanck; 🇫🇷 Saint Laurent Du Var, France

CHU de Toulouse; 🇫🇷 Toulouse, France