Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT04549896

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

Led by Elsan · Updated on 2024-06-26

130

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 90 years
  • Body mass index (BMI) of 40 kg/m2 or less
  • Signed informed consent before any study procedures
  • Ability to understand and comply with study procedures
  • Affiliated with or recipient of a social security scheme
  • Coronary artery chronic total occlusion (TIMI 0 flow for more than 3 months) with viable heart muscle and symptoms like CCS class 2 angina, NYHA class 2 dyspnea, documented ischemia, or ejection fraction less than 50%
  • Coronary angiography J-CTO score of 2 or higher (complex cases)
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Adults protected by law
  • Very frequent and irregular heart rhythm over 100 beats per minute
  • More than one CTO to be treated by PCI
  • Coronary angiography J-CTO score of 0 or 1
  • Hemodynamic instability
  • Anemia with hemoglobin less than 9 g/dl
  • Gastrointestinal bleeding
  • Low platelet count below 50,000/mm3
  • Severe valvular heart disease
  • CT scan already performed as part of standard care before inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Polyclinique Les Fleurs

Ollioules, France, 83190

Actively Recruiting

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Research Team

E

Eugenio LA SCALA, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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