Aortic Aneurysm and DissectionRESPIRATEVARNCT07863453
Pulmonary Complications Following TEVAR
An observational study of Aortic Aneurysm and Dissection and Thoracic Endovascular Aortic Repair, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm and Dissection, Thoracic Endovascular Aortic Repair
- How many people
- 385 participants
- Where
- 3 sitesItaly
- Study dates
- 20 Jan 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
ASST Grande Ospedale Metropolitano Niguarda
Milan
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Ospedale di Circolo ASST Sette Laghi
Varese
About this study
Official title: Prospective and Retrospective Observational Study of Pulmonary Complications Following Aortic Repair Using Thoracic Endograft (Thoracic Endovascular Aortic Repair, TEVAR)
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.
- Keywords
- tevar
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TEVAR cohort | patients who underwent TEVAR procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endpoint 1
Estimate of the proportion of patients with at least one pulmonary complication post TEVAR
Measured: From enrollment to the 1 year follow up
Secondary outcomes (2)
Endpoint 2
Calculation of the proportion of patients with postoperative pulmonary complications, analyzed by type and time of onset.
Measured: From enrollment to the 1 year follow up
Endpoint 3
Association between the development of pulmonary complications and possible risk factors
Measured: From enrollment to the 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start20 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm and DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 385 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SANTI TRIMARCHI, MEDICAL DOCTOR, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863453
- Sponsor's protocol ID
- 5650
- Acronym
- RESPIRATEVAR
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32628988Genovese 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 27832989Miyashita 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 32611930Cheng 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Retrospective Observational Study of Pulmonary Complications Following Aortic Repair Using Thoracic Endograft (Thoracic Endovascular Aortic Repair, TEVAR)
- ClinicalTrials.gov ID
- NCT07863453
- Acronym / sponsor ID
- RESPIRATEVAR / 5650
- Keywords
- tevar
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEVAR cohort | – | –patients who underwent TEVAR procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Endpoint 1
Time frame: From enrollment to the 1 year follow up
Estimate of the proportion of patients with at least one pulmonary complication post TEVAR
2 secondary outcomes
Endpoint 2
Time frame: From enrollment to the 1 year follow up
Endpoint 3
Time frame: From enrollment to the 1 year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Background: PubMed 32628988Upchurch 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.
- Background: PubMed 27832989Genovese 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.
- Background: PubMed 32611930Miyashita 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.
- Background: PubMed 20137879Cheng 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.
- Individual participant dataSharing planned: No
Related trials for Aortic Aneurysm and Dissection
RecruitingObservational study
Potential Diagnostic Biomarkers for Aortic Dissection in the Emergency Department
Aortic Dissection
Recruiting
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
Aortic Arch Aneurysm, Aortic Arch Dissection
Recruiting
Study Comparing Hemiarch Replacement and Hemiarch Plus Stent Implantation in Acute Aortic Dissection
Aortic Dissection
RecruitingPhase 3
Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection
Aortic Dissection, Inflammation
Recruiting
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SANTI TRIMARCHI, MEDICAL DOCTOR principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm and Dissection and Thoracic Endovascular Aortic Repair, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endpoint 1 (time frame: From enrollment to the 1 year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07863453, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.