Effect of preoperative coronary CT for planning of percutaneous coronary intervention for complex chronic total occlusion (CTS-C-CTOPCI): study protocol for an open-label randomised controlled trial

Trials

Study Protocol

Jean-Pascal Peyre¹  Eric Maupas²  Eugenio La Scala³ 

[1] ELSAN Group, Clinique Rhône Durance, 1750 chemin du Lavarin, 84000, Avignon, France;ELSAN Group, Hôpital Privé Les Franciscaines, 3 Rue Jean Bouin, 30000, Nîmes, France;ELSAN Group, Polyclinique Les Fleurs, 332 avenue Frédéric Mistral, 83190, Ollioules, France;

关键词: Chronic total occlusion;    Percutaneous coronary intervention;    Coronary computed tomographic angiography;   

DOI  :  10.1186/s13063-023-07458-y

 received in 2022-03-21, accepted in 2023-06-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundTreatment of chronic total occlusion (CTO) by percutaneous coronary intervention (PCI) is associated with the difficulty of guidewire manipulation through the occluded segment, particularly when there is hard tissue due to calcification. The purpose of this randomised controlled trial is to determine whether improved planning of CTO-PCI using coronary computed tomographic angiography (CCTA) (versus conventional angiography) increases success rates of wire crossing in ≤ 60 min in difficult cases.MethodsThis is a randomised controlled open-label multi-centre trial in a superiority framework with 1:1 allocation ratio. Participants (n = 130) will be randomised into two groups: the study group who will receive standard of care with the addition of preoperative coronary computed tomographic angiography (CT group), and the control group that will receive standard of care (angiography group). The primary endpoint will be the rate of successful wire crossing in ≤ 60 min in complex CTO (J-CTO ≥ 2). Wire crossing will be considered successful if TIMI flow 3 is restored and residual stenosis is < 30%. The safety endpoint will be mortality due to the intervention or major adverse cardiac events (MACE). Secondary endpoints are success rates at any time; total time of PCI; time of wire crossing; rate of PCI complications; radiation levels during PCI; volume of iodine contrast medium administered; and cost of the PCI.DiscussionThis randomised trial will provide insight into whether pre-procedural CCTA as opposed to conventional angiography for planning of CTO-PCI yield higher success rates of wire crossing in ≤ 60 min. Potential benefits of CCTA include shorter successful procedure times of CTO-PCI leading to less irradiation and contrast medium with lower complication rates.Trial registrationClinical Trials.gov NCT04549896. Registered on December 21, 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023