RecruitingNot ApplicableNCT04549896

Computed Tomography Scan in Complex Chronic Total Occlusion Percutaneous Coronary Intervention;

Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).


Sponsor

Elsan

Enrollment

130 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria7

  • Male or female ≥ 18 years old and ≤ 90 years old,
  • BMI ≤ 40 kg/m²,
  • Dated and signed informed consent, before any study-related procedures
  • Ability to understand and comply with the study procedures,
  • Affiliate or recipient of a social security scheme,
  • Coronary artery chronic total occlusion (TIMI 0 flow from > 3 months) associated with myocardial viability (intended like normokinetic/hypokinetic wall motion or instrumental data in favor of viability) associated with ≥ CCS2 angina or ≥ NHYA2 dyspnea or documented ischemia or ejection fraction <50%.
  • Coronary angiography J-CTO score ≥ 2 (complex cases)

Exclusion Criteria11

  • Pregnant or breastfeeding woman,
  • Adults patients protected by law,
  • Very frequent and irregular cardiac rhythm (>100/min.),
  • More than one CTO to be treated by PCI,
  • Coronary angiography J-CTO (Japan Chronic Total Occlusion) score 0/1
  • Hemodynamic instability,
  • Anemia < 9g/dl,
  • Gastrointestinal bleeding,
  • Thrombocytopenia with < 50 000/mm3 platelets count,
  • Severe valvular disease associated
  • CT-Scan performed as part of the standard of care pathology diagnosis, before the inclusion

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Interventions

PROCEDURECT scan

Surgeon will perform a CT scan before the surgery procedure (CTO PCI) in order to increase the success rate of the surgery.

PROCEDURENo CT scan

The surgery procedure (CTO PCI) will be performed following the standard of care, meaning that the surgeon will not perform a CT scan before the surgery procedure.


Locations(1)

Polyclinique Les Fleurs

Ollioules, France

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NCT04549896


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