search
Back to results

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

Primary Purpose

Chronic Total Occlusion of Coronary Artery, Optical Coherence Tomography, Ischemic Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Percutaneous recanalization of chronic total occlusion
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Total Occlusion of Coronary Artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Clermont-Ferrand
  • GHM de Grenoble
  • Bressollette
  • CHU de Nimes
  • CHU Poitiers
  • Institut A.Tzanck
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Successfully CTO recanalization

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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.
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.

Full Information

First Posted
June 20, 2017
Last Updated
April 13, 2021
Sponsor
Poitiers University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03209843
Brief Title
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
Acronym
PERFECTO
Official Title
Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
February 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Total Occlusion of Coronary Artery, Optical Coherence Tomography, Ischemic Cardiomyopathy, Neointimal Hyperplasia, Stent Thrombosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Successfully CTO recanalization
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Percutaneous recanalization of chronic total occlusion
Intervention Description
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 Measure Information:
Title
Percentage of uncovered stent struts
Description
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.
Time Frame
3 months
Title
Percentage of malapposed stent struts
Description
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.
Time Frame
3 months
Title
Percentage of neointimal hyperplasia proliferation
Description
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.
Time Frame
3 months
Title
Minimal lumen area
Description
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Time Frame
3 months
Title
Minimal lumen diameter
Description
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
Time Frame
3 months
Title
Thrombus
Description
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Time Frame
3 months
Title
Edge dissection
Description
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Relevancy of immediate post-PCI OFDI analysis
Description
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.
Time Frame
Day one
Title
Impact of the technique employed for CTO revascularization on the reendothelialization
Description
Comparison of primary composite endpoint between different way of recanalization: Anterograde. Retrograde. Dissection/re-entry.
Time Frame
3 months
Title
One year clinical follow-up
Description
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
Time Frame
One year
Title
Angina
Description
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.
Time Frame
One year
Title
Dyspnea
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Levesque, MD
Organizational Affiliation
University Hospital of Poitiers, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
GHM de Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Bressollette
City
Nantes
Country
France
Facility Name
CHU de Nimes
City
Nimes
ZIP/Postal Code
30000
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut A.Tzanck
City
Saint Laurent Du Var
ZIP/Postal Code
06000
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs