The use of Contrast Enhanced Transesophageal Echocardiography in thoracic endovascular aortic repair (TEVAR). Feasibility and safety of a new tool for intraoperative monitoring and follow up. - ND
- Conditions
- descending thoracic aorta diseasesMedDRA version: 9.1Level: SOCClassification code 10007541
- Registration Number
- EUCTR2010-018767-42-IT
- Lead Sponsor
- FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
patients elegible for endovascular treatment of descending thoracic aorta diseases. Patient will be already known for type 2 aortic dissection (n=x), for aortic penetrating ulcer, for anurysms of descending thoracic aorta (n=y). The indication for TEVAR, as for open surgery, is generally accepted for aneurysm of the descending thoracic aorta greater than 5.5 cm. Another indication is type B aortic dissection with aneurismal evolution that reach the 5.5 cm criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
patients aged below 18 years old; contraindication to M.D.C. use
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to assess the possible role of contrast-enhanced TEE in the operatory room and evaluate its diagnostic accuracy in early endoleak detection, compared to TEE alone.;Secondary Objective: to identify the diagnostic accuracy of contrast-enhanced TEE in the follow up of patients who previosly underwent TEVAR.;Primary end point(s): diagnostic accuracy of contrast-enhanced TEE
- Secondary Outcome Measures
Name Time Method