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Completed

NCT Number: NCT03209843

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Clermont-Ferrand, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous recanalization of chronic total occlusion

Procedure

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.

Primary outcomes

  1. Percentage of uncovered stent struts

    Time frame: 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.

  2. Percentage of malapposed stent struts

    Time frame: 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.

  3. Percentage of neointimal hyperplasia proliferation

    Time frame: 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.

  4. Minimal lumen area

    Time frame: 3 months

    Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.

  5. Minimal lumen diameter

    Time frame: 3 months

    Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted

  6. Thrombus

    Time frame: 3 months

    Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.

  7. Edge dissection

    Time frame: 3 months

    Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.

Secondary outcomes

  1. Relevancy of immediate post-PCI OFDI analysis

    Time frame: 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:

    • Dissection or thrombus.
    • Residual stenosis.
    • Stent malapposition defined by at least one malapposed strut.
    • Residual stenosis.

  2. Impact of the technique employed for CTO revascularization on the reendothelialization

    Time frame: 3 months

    Comparison of primary composite endpoint between different way of recanalization:

    • Anterograde.
    • Retrograde.
    • Dissection/re-entry.

  3. One year clinical follow-up

    Time frame: 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.

    • Death all-cause
    • Myocardial infarction
    • Stroke
    • Sudden death
    • Hospitalization for cardiac cause
    • Severe hemorrhage

  4. Angina

    Time frame: 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.

  5. Dyspnea

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure

Acronym: PERFECTO

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 6, 2017
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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