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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-018767-42-IT
Enrollment
Unknown
Registered
2010-03-03
Start date
2011-05-06
Completion date
Unknown
Last updated
2012-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

descending thoracic aorta diseases MedDRA version: 9.1 Level: SOC Classification code 10007541

Interventions

Trade Name: SONOVUE Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Sulfur hexafluoride Concentration unit: ml millilitre(s) Concentration type: equal Concentrat

Sponsors

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: patients aged below 18 years old; contraindication to M.D.C. use

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026