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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03209843
Other study ID # PERFECTO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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