Peri-operative MortalityNCT04016545
Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
An observational study of Peri-operative Mortality, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-operative Mortality
- What is being tested?
- Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 1 Aug 2027
- How long will I take part?
- 24 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients eligible for elective TEVAR treatable with low-profile endoprothesis
Who may be able to join
- Patients with indications for elective TEVAR
Who cannot join
- Incapability to provide consent
- Patients not eligible for TEVAR
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00167
Giovanni Tinelli, 0039 0630157205, giovanni.tinelli@policlinicogemelli.it
About this study
The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.
- Conditions
- Peri-operative Mortality
- Being tested
- Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)Device
Aortic aneurysm exclusion through endovascular procedure
| Study group | Role | What they receive |
|---|---|---|
| Treated patients | Not described Receives: Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Post-operative mortality (intra-operatory and up to 30 days post-surgery)
Measured: 30 days
Secondary outcomes (1)
Complications
Complications during follow-up
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Oct 2019
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-operative MortalityStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TINELLI GIOVANNI, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016545
- Sponsor's protocol ID
- 30027/19
- Status last verified
- Mar 2025
- First submitted
- 9 Jul 2019
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices
- ClinicalTrials.gov ID
- NCT04016545
- Acronym / sponsor ID
- 30027/19
- Conditions
- Peri-operative Mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 11 Jul 2019 (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 aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | – | Device: Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients eligible for elective TEVAR treatable with low-profile endoprothesis
Key inclusion criteria (1 listed)
- Patients with indications for elective TEVAR
Key exclusion criteria (3 listed)
- Incapability to provide consent
- Patients not eligible for TEVAR
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)Aortic aneurysm exclusion through endovascular procedure | Device | Treated patients |
Primary outcome
Mortality
Time frame: 30 days
Post-operative mortality (intra-operatory and up to 30 days post-surgery)
1 secondary outcome
Complications
Time frame: 24 months
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 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-operative Mortality, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Giovanni Tinelli (0039 0630157205, giovanni.tinelli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2025.