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NCT05111496 Clinical Trial

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

Chronic Total Occlusion Clinical Trial

— Optidose  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05111496
Other study ID # 2019-A02398-49
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 24, 2020
Est. completion date November 24, 2021

Study information
Verified date October 2021
Source Ramsay Générale de Santé
Contact Jean-François Oudet
Phone 0683346567
Email jf.oudet@ecten.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 85
Est. completion date November 24, 2021
Est. primary completion date October 6, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Gafchromic film
Before the X-ray radiation, a Gafchromic film will be placed on the patient's back at the start of the operation

Locations
Country Name City State
France Hôpital privé La Louvière Lille Haut De France

Sponsors (2)
Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose measured to the patient's skin at the entrance to the X-ray beam Dose expressed in Gy (Peak skin dose). 1 month
See also
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Completed NCT02358629 - A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO). N/A
Completed NCT00670436 - The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions Phase 2
Completed NCT04862559 - A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions N/A
Active, not recruiting NCT02227771 - Consistent CTO Trial N/A
Recruiting NCT05458999 - Decreasing Patient Anxiety During Revascularization of Chronic Total Coronary Occlusions Using Virtual Reality Glasses. N/A