ClinicalTrials.gg
Sign In
Active, not recruitingNCT07863453RESPIRATEVARUpdated Oct 7, 2026

Pulmonary Complications Following TEVAR

An observational study in Aortic Aneurysm and Dissection and Thoracic Endovascular Aortic Repair, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Active, not recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational

Updated Oct 7, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
385
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

To date, data in the literature regarding pulmonary complications following TEVAR are quite limited. However, various experiences have been reported, including a study of 75 TEVAR procedures that described an incidence of respiratory failure in approximately 15% of cases, with a significantly higher mortality rate among these patients. Furthermore, a meta-analysis identified respiratory complications and pneumonia in 16% and 11% of cases, respectively.

It is evident, therefore, that although often unreported or underestimated, respiratory complications account for a significant proportion of morbidity following TEVAR.

This study aims to examine in greater depth the risk factors, types of pulmonary complications, and management strategies associated with TEVAR, with the goal of optimizing prevention and postoperative recovery for these patients.

Prospective patient recruitment will last 12 months; data collection will include pre-, peri-, and post-operative data up to the first annual follow-up, which is part of the standard of care. The same data will also be collected for the retrospective cohort. Data analysis will be performed in the months following the conclusion of patient enrollment.

02

Conditions studied

  • Aortic Aneurysm and Dissection
  • Thoracic Endovascular Aortic Repair

Browse trials for

Keywords

  • tevar
03

In context

Aortic Dissection

387 studies on the registry are indexed under Aortic Dissection; 115 are open to participants now.

This study's planned enrollment of 385 is above the median of 191 across 182 observational studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 232 studies on the registry; 83 are open to participants now.

Browse Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with degenerative and/or traumatic aortic disease who are candidates for TEVAR and enrolled at one of the three vascular surgery centers participating in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
385 participants (estimated)
Patient registry
No

Groups and cohorts

  • TEVAR cohort

    patients who underwent TEVAR procedures

06

What researchers measure

Primary outcomes

  1. Endpoint 1

    Estimate of the proportion of patients with at least one pulmonary complication post TEVAR

    Time frame: From enrollment to the 1 year follow up

Secondary outcomes

  1. Endpoint 2

    Calculation of the proportion of patients with postoperative pulmonary complications, analyzed by type and time of onset.

    Time frame: From enrollment to the 1 year follow up

  2. Endpoint 3

    Association between the development of pulmonary complications and possible risk factors

    Time frame: From enrollment to the 1 year follow up

07

Study locations

3 sites
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Italy
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
    Milan, Italy
  • Ospedale di Circolo ASST Sette Laghi
    Varese, Italy
08

References and documents

Publications

  • Upchurch GR Jr, Escobar GA, Azizzadeh A, Beck AW, Conrad MF, Matsumura JS, Murad MH, Perry RJ, Singh MJ, Veeraswamy RK, Wang GJ. Society for Vascular Surgery clinical practice guidelines of thoracic endovascular aortic repair for descending thoracic aortic aneurysms. J Vasc Surg. 2021 Jan;73(1S):55S-83S. doi: 10.1016/j.jvs.2020.05.076. Epub 2020 Jul 3. PubMed 32628988 ↗
  • Genovese EA, Fish L, Chaer RA, Makaroun MS, Baril DT. Risk stratification for the development of respiratory adverse events following vascular surgery using the Society of Vascular Surgery's Vascular Quality Initiative. J Vasc Surg. 2017 Feb;65(2):459-470. doi: 10.1016/j.jvs.2016.07.119. Epub 2016 Nov 7. PubMed 27832989 ↗
  • Miyashita F, Kinoshita T, Suzuki T, Asai T. Respiratory Failure after Open Descending Aortic Aneurysm Repair: Risk Factors and Outcomes. Ann Thorac Cardiovasc Surg. 2021 Feb 20;27(1):41-48. doi: 10.5761/atcs.oa.20-00020. Epub 2020 Jul 2. PubMed 32611930 ↗
  • Cheng D, Martin J, Shennib H, Dunning J, Muneretto C, Schueler S, Von Segesser L, Sergeant P, Turina M. Endovascular aortic repair versus open surgical repair for descending thoracic aortic disease a systematic review and meta-analysis of comparative studies. J Am Coll Cardiol. 2010 Mar 9;55(10):986-1001. doi: 10.1016/j.jacc.2009.11.047. PubMed 20137879 ↗

Individual participant data

Plan to share: No

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Dec 2026, 23 months after the start.

Of 63 non-industry observational studies under Aortic Dissection, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 135. This study's planned 23 months is below that.

Counting every sponsor, half of 80 studies reached it within 83 months; a quarter within 31 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 2, 2026
First posted
Oct 7, 2026
StartActual
Jan 20, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07863453
Lead sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Responsible party
Sponsor
First posted
Oct 7, 2026
Start date
Jan 20, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 7, 2026

Study contacts

SANTI TRIMARCHI, MEDICAL DOCTOR
principal investigator · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aortic Dissection →

Other studies from this sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico →

Start the discussion