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

• ClinicalTrials.gov Identifier: NCT03209843
• Recruitment Status: Completed
• First Posted: July 6, 2017
• Last Update Posted: April 14, 2021
• Sponsor: Poitiers University Hospital
• Information provided by (Responsible Party): Poitiers University Hospital

Tracking Information

• First Submitted Date: June 20, 2017
• First Posted Date: July 6, 2017
• Last Update Posted Date: April 14, 2021
• Actual Study Start Date: March 7, 2018
• Actual Primary Completion Date: February 12, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2017)

• 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.
• 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.
• 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.
• Minimal lumen area [ Time Frame: 3 months ]
  Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
• Minimal lumen diameter [ Time Frame: 3 months ]
  Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
• Thrombus [ Time Frame: 3 months ]
  Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
• Edge dissection [ Time Frame: 3 months ]
  Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.

Original Primary Outcome Measures (submitted: July 3, 2017)

Composite of data measured by OFDI 3 months after CTO recanalization [ Time Frame: 3 months ]

Percentage of uncovered struts, percentage of malapposition, percentage of neointimal hyperplasia proliferation, presence of thrombus, presence of edge dissection, minimal lumen area, minimal lumen diameter

Current Secondary Outcome Measures (submitted: July 20, 2017)

• 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.
• 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.
• 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
• 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.
• 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.

Original Secondary Outcome Measures (submitted: July 3, 2017)

• 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.
• 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.
• 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. 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
• Official Title: Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Study Arms

Successfully CTO recanalization

Intervention: Procedure: Percutaneous recanalization of chronic total occlusion

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2020): 122
• Original Estimated Enrollment (submitted: July 3, 2017): 150
• Actual Study Completion Date: February 12, 2021
• Actual Primary Completion Date: February 12, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03209843
• Other Study ID Numbers: PERFECTO
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Poitiers University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Poitiers University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Poitiers University Hospital
• Verification Date: April 2021