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

Ischemic Cardiomyopathy Clinical Trial

— PERFECTO  

Official title:

Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209843
• Other study ID #: PERFECTO
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: February 12, 2021

Study information

• Verified date: April 2021
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Chronic Total Occlusion of Coronary Artery
• Hyperplasia
• Ischemic Cardiomyopathy
• Neointimal Hyperplasia
• Optical Coherence Tomography
• Stent Thrombosis
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand
France	GHM de Grenoble	Grenoble
France	Bressollette	Nantes
France	CHU de Nimes	Nimes
France	CHU Poitiers	Poitiers
France	Institut A.Tzanck	Saint Laurent Du Var
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Minimal lumen area	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.	3 months
Primary	Minimal lumen diameter	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted	3 months
Primary	Thrombus	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.	3 months
Primary	Edge dissection	Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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