Status:
COMPLETED
Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.
Lead Sponsor:
University of Lausanne Hospitals
Collaborating Sponsors:
Centre de recherche clinique - FBM-CHUV
Conditions:
Arterial Spasm
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Radial artery access use in percutaneous cardiac interventions (PCI) is associated with a lower risk of vascular complications, bleeding and major adverse cardiac events including cardiac death in the...
Detailed Description
Multicenter, randomised controlled trial, designed to evaluate the noninferiority of the intravenous administration of vasodilatory drugs in comparison with the actual gold standard intra-arterial rad...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Clinical indication for a coronary angiogram by radial route
- Age ≥18 years old
- Chronic coronary disease or stable acute coronary syndrome (NSTEMI, Non-ST Elevation Myocardial Infarction)
- Exclusion criteria:
- ST-Elevation Myocardial infarction
- Severe aortic stenosis (aortic valve area \<0.8 cm2 or mean gradient \> 40 mmHg)
- Severe left ventricular dysfunction (left ventricular ejection fraction \< 30%).
- Heart failure, hemodynamic instability or severe hypotension (systolic arterial pressure \< 90 mm Hg or heart rate \< 45 bpm).
- Atrioventricular disturbances (atrioventricular block 2° or 3°).
- Contraindications to the class of drugs used in the trial, e.g. known hypersensitivity or allergy to class of drugs or the investigational
- Women who are pregnant or breast feeding, Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- Psychological disorders, dementia, etc. of the participant.
Exclusion
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04317846
Start Date
March 22 2021
End Date
June 30 2024
Last Update
August 6 2024
Active Locations (2)
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1
Rubimbura Vladimir
Lausanne, Canton of Vaud, Switzerland, 1011
2
Morges Hospital
Morges, Canton of Vaud, Switzerland, 1110