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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04014907
Other study ID # 15530/19
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date December 31, 2024

Study information

Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Giovanni Tinelli
Phone 0039 0630157205
Email giovanni.tinelli@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to evaluate peri-operative mortality and main post-operative complications (for example cardiovascular, respiratory and renal) in patients treated with frozen elephant trunk techinque.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date May 2023
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients with post-dissection arch aneurysm with a maximal aortic diameter >55mm or rapid growth (>10mm/year) Exclusion Criteria: - Emergency setting

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Frozen Elephant Trunk Technique
Endovascular technique forTAA repair

Locations

Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS Roma RM

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Peri-operatory mortality 36 months
Secondary Post-operatory complications 36 months
See also
  Status Clinical Trial Phase
Completed NCT02208648 - Coronary Assessment for Mortality Prediction
Recruiting NCT04016545 - Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices