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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209843
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion of Coronary Artery Optical Coherence Tomography Ischemic Cardiomyopathy Neointimal Hyperplasia Stent Thrombosis Procedure: Percutaneous recanalization of chronic total occlusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : March 14, 2021
Estimated Study Completion Date : March 14, 2021

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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:

    1. Dissection or thrombus.
    2. Residual stenosis.
    3. Stent malapposition defined by at least one malapposed strut.
    4. 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:

    1. Anterograde.
    2. Retrograde.
    3. 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.

    1. Death all-cause
    2. Myocardial infarction
    3. Stroke
    4. Sudden death
    5. Hospitalization for cardiac cause
    6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209843


Locations
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France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
GHM de Grenoble
Grenoble, France, 38000
Bressollette
Nantes, France
CHU de Nimes
Nimes, France, 30000
CHU Poitiers
Poitiers, France, 86021
Institut A.Tzanck
Saint Laurent Du Var, France, 06000
CHU de Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
Poitiers University Hospital
Investigators
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Principal Investigator: Sebastien Levesque, MD University Hospital of Poitiers, Department of Cardiology
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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03209843    
Other Study ID Numbers: PERFECTO
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombosis
Cardiomyopathies
Hyperplasia
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Pathologic Processes