Ireland
--:--IST
Active, not recruiting Observational

Pulmonary Complications Following TEVAR

NCT07863453 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-20
Last updated
2026-10-07

Condition(s) studied

Aortic Aneurysm and DissectionThoracic Endovascular Aortic Repair

Study summary

The goal of this observational study is to analyze pulmonary complications after TEVAR procedures and to identify the risk factors associated with these complications. The study population will consist of adult patients with degenerative and/or traumatic aortic disease who are candidates for TEVAR or who have undergone TEVAR between October 1, 2018, and December 31, 2025, with scheduled follow-up completion by December 2026. The aims of the study are:

* To provide information on pulmonary complications following TEVAR and their associated risk factors.
* To contribute to the planning of preventive interventions and targeted treatments to reduce pulmonary complications following TEVAR.
* To improve clinical outcomes for patients undergoing TEVAR.

Participants will be recruited retrospectively and prospectively.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients undergoing TEVAR procedures with a proximal landing zone ranging from Ishimaru Zone 1 to Ishimaru Zone 4 and a distal landing zone in Ishimaru Zone 5 * Patients undergoing TEVAR as a proximal "Step 1" procedure within the context of a thoracoabdominal aneurysm endovascular repair (FEVAR and/or BEVAR) involving an interval of at least 30 days between Step 1 and Step 2 * Patients meeting the above criteria who underwent the procedure on either an elective or urgent basis Exclusion Criteria: * Patients who underwent TEVAR as a proximal extension of a prior endovascular repair of a thoracoabdominal aneurysm (FEVAR and/or BEVAR) within the last year * Patients who underwent TEVAR procedures with a proximal landing zone in Ishimaru Zone 0 * Patients diagnosed with lung cancer, prior tracheostomy, or chest trauma

Primary outcome measure(s)

  • Endpoint 1 — From enrollment to the 1 year follow up
    Estimate of the proportion of patients with at least one pulmonary complication post TEVAR

Trial sites (3)

FacilityCityRegionStatus
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy
Ospedale di Circolo ASST Sette Laghi Varese Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07863453 on ClinicalTrials.gov ↗ ← All trials in Italy