JetCTO
Registry
Registry
A retrospective, multi-center registry evaluating the clinical and angiographic outcome of covered stents for the treatment of coronary perforation during CTO procedures.
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RATIONALE
ENDPOINTS
CRITERIA
PROCEDURE PROTOCOL
STEERING COMITTEE
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 patient-related:
1. Patient <18 years old
2. Pregnant female
3. Contraindication to dual antiplatelet therapy
4. Thrombocytopenia <100 000
PROCEDURE PROTOCOL
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 COMITTEE
JetCTO is governed by a pan-European Steering Committee which is co-chaired by the coordinating investigators (Executive Committee).
Executive Committee
Alexandre Avran
Interventional Cardiologist,
Centre Hospitalier de Valenciennes,
Valenciennes, France
Kambis Mashayekhi
Interventional Cardiologist,
MediClin Heartcenter,
Lahr, Germany
Stéphane Carlier
Interventional Cardiologist,
CHU Ambroise Paré,
Mons, Belgium
Stéphane Rinfret
Interventional Cardiologist,
Emory Heart Center,
Atlanta, United States
Project management
Chadi Ghafari
Mons – Belgium
Study coordination
Egina Timiras
Mons – Belgium
Statistics coordination
Alessandro Scalia
Mons – Belgium
Data Safety Monitoring Board
Roberto Garbo
Interventional Cardiologist,
Maria Pia Hospital,
Torino, Italy
Data Safety Monitoring Board
Thomas Hovasse
Interventional Cardiologist
Hôpital privé Jacques Cartier,
Massy, France