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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand
  • Grenoble, France, 38000
    • GHM de Grenoble
  • Nantes, France
    • Bressollette
  • Nimes, France, 30000
    • CHU de Nîmes
  • Poitiers, France, 86021
    • CHU Poitiers
  • Saint Laurent Du Var, France, 06000
    • Institut A.Tzanck
  • Toulouse, France, 31000
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Successfully CTO recanalization	Procedure: Percutaneous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of uncovered stent struts	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.	3 months
Percentage of malapposed stent struts	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.	3 months
Percentage of neointimal hyperplasia proliferation	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.	3 months
Minimal lumen area	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.	3 months
Minimal lumen diameter	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted	3 months
Thrombus	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.	3 months
Edge dissection	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relevancy of immediate post-PCI OFDI analysis	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: Dissection or thrombus.; Residual stenosis.; Stent malapposition defined by at least one malapposed strut.; Residual stenosis.	Day one
Impact of the technique employed for CTO revascularization on the reendothelialization	Comparison of primary composite endpoint between different way of recanalization: Anterograde.; Retrograde.; Dissection/re-entry.	3 months
One year clinical follow-up	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.; Death all-cause; Myocardial infarction; Stroke; Sudden death; Hospitalization for cardiac cause; Severe hemorrhage	One year
Angina	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.	One year
Dyspnea	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.	One year

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Investigators: Principal Investigator: Sebastien Levesque, MD, University Hospital of Poitiers, Department of Cardiology

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): February 12, 2021
• Study Completion (Actual): February 12, 2021

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Hyperplasia; Thrombosis; Cardiomyopathies
• Other Study ID Numbers: PERFECTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No