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Evaluation of the Radiological Dose Delivered to Risky Interventional Cardiology Patients (Optidose)

R

Ramsay Générale de Santé

Status

Unknown

Conditions

Chronic Total Occlusion
X-rays; Effects

Treatments

Radiation: Gafchromic film

Study type

Observational

Funder types

Other

Identifiers

NCT05111496
2019-A02398-49

Details and patient eligibility

About

The purpose of this study is therefore to study the actual doses of X-rays delivered to the patient's skin during recanalization of a coronary artery in a context of Chronic Total Occlusion

Enrollment

85 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient over 18 years-old
  • Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma> 3Gy): complex coronary dilation, coronary recanalization
  • Patient benefiting from a social protection insurance
  • Patient having been informed and not objecting to this research

Exclusion criteria

  • Patient refusal to participate in the study
  • Patient with known radiosensitivity factors (eg: Lupus)
  • Patient having had radiotherapy treatment of the thoracic region.
  • Patient whose sum of radiation doses to the skin> 0.5 Gy in the thoracic region in the 3 months preceding inclusion.
  • Patient participating in another clinical study
  • Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant or breastfeeding woman
  • Patient hospitalized without consent.

Trial design

85 participants in 1 patient group

Patient requiring intervention (complex coronary dilation or coronary recanalization)
Description:
Patient requiring intervention with a predicted risk of exceeding the radiological threshold (Air Kerma\> 3Gy): complex coronary dilation, coronary recanalization
Treatment:
Radiation: Gafchromic film

Trial contacts and locations

1

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Central trial contact

Marie-Hélène Barba; Jean-François Oudet

Data sourced from clinicaltrials.gov

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