Rationale
Endpoints
Criteria
Procedure protocole
Steering Committee
Rationale
Coronary perforation occurring during a CTO PCI is a rare complication with potential major adverse cardiac events. The long-term clinical and angiographic outcome of such perforation that needs sealing with a covered stent, has to be refined in a large international registry. The purpose of this study, sponsored by the University of Mons with an unrestricted educational grant from the ML CTO Academy, is to describe in a large international collaborative network the occurrence and outcome of coronary perforations complicating a CTO procedure.
The objective of the registry is to collect retrospective multicentric observational data of a rare major adverse event that can occur during a percutaneous coronary intervention (PCI) for the treatment of a chronically occluded coronary artery (CTO). As such a power calculation is not indicated, we will collect the events from all centers willing to participate in this collective registry.
Endpoints
Primary Endpoint:
To assess the long-term (≥ 6 months) clinical follow up of patients suffering from a coronary perforation during a CTO procedure.
Secondary Endpoint:
1. Angiographic patency of any covered stent used to seal the perforation;
2. Rate of complications (composite of cardiac death, myocardial infarction, major bleeding and cardiac tamponade) of the index procedure.
Criteria
Inclusion critera:
1. Chronic total occlusion lesion
2. Objective perforation during CTO procedure
3. Covered stent implantation
4. Angiographic follow-up procedure
Exclusion Criteria:
1. Patient <18 years old
2. Pregnant female
3. Contraindication to dual antiplatelet therapy
4. Thrombocytopenia <100 000
Procedure protocole
Study population: Retrospective clinical data of eligible patients, who meet the inclusion criteria, will be collected in an on-line database.
Patients will be treated following local standards.
For this registry, the clinical events will be anonymously collected in a secured on-line database indicated for clinical research (https://projectredcap.org/)
Study Initiation: September 2021
Study End: March 2023
Steering Committee
JetCTO is governed by a pan-European Steering Committee which is co-chaired by the coordinating investigators (Executive Committee).
Executive Committee
![](https://academy.mlcto.com/wp-content/uploads/2021/02/avran2.jpg)
Alexandre Avran
Interventional Cardiologist,
Centre Hospitalier de Valenciennes,
Valenciennes, France
![](https://academy.mlcto.com/wp-content/uploads/2021/02/Kambis-Mashayekhi.jpg)
Kambis Mashayekhi
Interventional Cardiologist
Bad krozingen,
Germany
![](https://academy.mlcto.com/wp-content/uploads/2021/02/carlier-1.jpg)
Stéphane Carlier
Interventional Cardiologist
Mons,
Belgium
![](https://academy.mlcto.com/wp-content/uploads/2022/10/rinfret-200.jpg)
Stéphane Rinfret
Interventional Cardiologist,
Emory Heart Center,
Atlanta, United States
Project management
![Chadi Ghafari](https://academy.mlcto.com/wp-content/uploads/2021/12/Chadi-Ghafari-NB.jpg)
Chadi Ghafari
Mons – Belgium
Study coordination
![Dummy Image](https://academy.mlcto.com/wp-content/plugins/movedo-extension/assets/images/empty/full.jpg)
Egina Timiras
Mons – Belgium
Statistics coordination
![Alessandro Scalia](https://academy.mlcto.com/wp-content/uploads/2021/12/Alessandro-Scalia-NB.jpg)
Alessandro Scalia
Mons – Belgium
Data Safety Monitoring Board
![](https://academy.mlcto.com/wp-content/uploads/2021/02/roberto_garbot-1.jpg)
Roberto Garbo
Interventional Cardiologist,
Maria Pia Hospital,
Torino, Italy
Data Safety Monitoring Board
![](https://academy.mlcto.com/wp-content/uploads/2021/02/thomas-hovasse-1.jpg)
Thomas Hovasse
Interventional Cardiologist
Hôpital privé Jacques Cartier,
Massy, France