NCT04317846Completed
Transradial Evaluation Study of Diameter Increase After Vasodilatory Drugs Administration.
TransRadIal Evaluation STudy of diamEter Increase After Vasodilatory Drugs Administration: The TRIESTE Randomized Study
Source: ClinicalTrials.gov · Last updated 6 Aug 2024
Brief summary (registry, in English)
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 long-term follow-up. Intra-radial administration of vasodilatory drugs, transiently painful for the patient, reduces the risk of spasm and is currently the standard technique performed worldwide. However, the efficacy of intravenous administration of vasodilatory drugs has never been evaluated.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 165 (actual)
- First submitted
- 18 Mar 2020
- Start date
- 22 Mar 2021
- Primary completion date
- 13 Feb 2024
- Lead sponsor
- University of Lausanne Hospitals
- Diseases
- Coronary artery disease
- NCT number
- NCT04317846
What you commit to
- Study type: Interventional
- Participants enrolled: 165
- From 22 Mar 2021 to the primary completion date, 13 Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
Other illness
- ST-Elevation Myocardial infarction
- Heart failure, hemodynamic instability or severe hypotension (systolic arterial pressure \< 90 mm Hg or heart rate \< 45 bpm).
- Contraindications to the class of drugs used in the trial, e.g. known hypersensitivity or allergy to class of drugs or the investigational
- Psychological disorders, dementia, etc. of the participant.
Lab values
- Severe left ventricular dysfunction (left ventricular ejection fraction \< 30%).
Other
- Severe aortic stenosis (aortic valve area \<0.8 cm2 or mean gradient \> 40 mmHg)
- Atrioventricular disturbances (atrioventricular block 2° or 3°).
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rubimbura Vladimir Coordinator of this site? Confirm its status | Lausanne | Switzerland | Unknown status |
| Morges Hospital Coordinator of this site? Confirm its status | Morges | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.