Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO)
PERFECTO
1 other identifier
interventional
122
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedStudy Start
First participant enrolled
March 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2021
CompletedApril 14, 2021
April 1, 2021
2.9 years
June 20, 2017
April 13, 2021
Conditions
Outcome Measures
Primary Outcomes (7)
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
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
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
Minimal lumen area
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
3 months
Minimal lumen diameter
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted
3 months
Thrombus
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
3 months
Edge dissection
Measured by OFDI 3 months after CTO recanalization every millimeter over entire length of each stent implanted.
3 months
Secondary Outcomes (5)
Relevancy of immediate post-PCI OFDI analysis
Day one
Impact of the technique employed for CTO revascularization on the reendothelialization
3 months
One year clinical follow-up
One year
Angina
One year
Dyspnea
One year
Study Arms (1)
Successfully CTO recanalization
OTHERInterventions
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.
Eligibility Criteria
You may qualify if:
- Successfully CTO revascularization by PCI with immediate post-PCI OFDI analysis
- months follow-up with OFDI analysis of the recanalized coronary artery
- Aged 18 or over
- Written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000, France
GHM de Grenoble
Grenoble, 38000, France
Bressollette
Nantes, France
CHU de Nimes
Nîmes, 30000, France
CHU Poitiers
Poitiers, 86021, France
Institut A.Tzanck
Saint-Laurent-du-Var, 06000, France
CHU de Toulouse
Toulouse, 31000, France
Related Publications (1)
Levesque S, Faurie B, Lattuca B, Lemoine J, Pitchecanin G, Motreff P, Bressollette E, Ragot S, Bouleti C, Christiaens LP. Optical Coherence Tomography to Better Assess Chronic Total Occlusion Percutaneous Intervention Results: The PERFECTO Study. JACC Adv. 2025 Oct;4(10 Pt 2):102125. doi: 10.1016/j.jacadv.2025.102125. Epub 2025 Sep 9.
PMID: 40930013DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien Levesque, MD
University Hospital of Poitiers, Department of Cardiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
July 6, 2017
Study Start
March 7, 2018
Primary Completion
February 12, 2021
Study Completion
February 12, 2021
Last Updated
April 14, 2021
Record last verified: 2021-04