Aneurysms Aortic ArchFETOPTNCT03600077
Evaluation of Supra-aortic Trunks Debranching Techniques in Open Arch Repair by Means of Frozen Elephant Trunk Procedure With Two Configurations of the Jotec E-Vita Hybrid Graft (FETOPT)
An observational study of Aneurysms Aortic Arch, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
To evaluate two different supra-aortic trunks debranching techniques during open repair of aortic arch aneurysms by means of Frozen Elephant Trunk procedure with two configurations of the Jotec E-Vita hybrid graft. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysms Aortic Arch
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 19 Jul 2018to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Adult, Older adult
Study population: The Investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 30 patients affected by extensive proximal aortic pathology treated at San Raffaele Hospital between December 2009 and January 2017 by means of Frozen Elephant Trunk technique, and of those of the next 20 patients who will be treated with the same procedure.
Who may be able to join
- patient undergoing treatment of extensive proximal aortic pathology at San Raffaele Hospital since December 2009
Who cannot join
- extensive proximal aortic pathology treated by techniques other than frozen elephant trunk : total open aortic repair, total endovascular aortic repair, hybrid endovascular aortic repair in zone 0.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Supra-aortic Trunks Debranching Techniques in Open Arch Repair by Means of Frozen Elephant Trunk Procedure With Two Configurations of the Jotec E-Vita Hybrid Graft
To evaluate two different supra-aortic trunks debranching techniques during open repair of aortic arch aneurysms by means of Frozen Elephant Trunk procedure with two configurations of the Jotec E-Vita hybrid graft.
Read the detailed description
Open management of extensive pathology of the proximal aorta, namely ascending aorta, aortic arch, and descending thoracic aorta (DTA) requires sequential treatment of each segment involved. According to the etiopathogenesis and clinical history of the disease, each segment can be treated independently or in association with the other portions of diseased aorta.
The current standard of treatment for arch aneurysmal disease extending into the DTA is the elephant trunk technique: both conventional and "frozen". The first requires open repair of the aortic arch with the use of a conventional surgical graft which distal end is left dangling in the DTA and will be the site of the proximal anastomosis of the subsequent repair of the thoracic aneurysm. The frozen elephant trunk (FET) technique differs from the first for the graft employed: this graft has a distal stented portion which is deployed in the DTA and facilitates subsequent endovascular management of the thoracic pathology.
In both the conventional elephant trunk and frozen elephant trunk the supra-aortic trunks (innominate artery, left carotid artery and left subclavian artery) need to be reimplanted on the surgical graft with variable configurations.
Debranching and reimplantation of such vessels can occur with variable configurations and either before or after the substitution of the pathologic aorta which is performed during cardiac arrest and extra-corporeal circulation (ECC) The first design has a straight tubual graft with self-expanding stents in the distal portion and has been employed at department of Vascular Surgery in San Raffaele Hospital, from December 2009 to February 2016. The second design has two side-branches on the non-stented proximal portion which facilitate debranching of the supra-aortic trunks before cardiac arrest and allow early reperfusion of the visceral vessels during extra-corporeal circulation . This graft has been introduced in practice at department of Vascular Surgery at San Raffaele Hospital in November 2016.
The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 30 patients affected by extensive proximal aortic pathology treated at department of Vascular Surgery in San Raffaele Hospital between December 2009 and January 2017 by means of Frozen Elephant Trunk technique, and of those of the next 20 patients who will be treated with the same procedure.
- Conditions
- Aneurysms Aortic Arch
- Medical subject headings
- Aneurysm, Aortic Arch
What is being measured
The primary outcome is the main question the study is designed to answer.
Extracorporeal circulation times (minutes)
- Extracorporeal circulation time
Measured: Intraoperative
antegrade cerebral perfusion time (minutes)
- antegrade cerebral perfusion time
Measured: Intraoperative
Lower limb perfusion time (minutes)
- Lower limb perfusion time
Measured: Intraoperative
Secondary outcomes (5)
Clinical 30-day results (Percent of participants with the clinical outcome)
- Mortality (%)
Measured: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
- Stroke (%)
Measured: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
- Spinal cord ischemia ( %)
Measured: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
- Prolonged mechanical ventilation: >48h ( %)
Measured: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
- Renal impairment (%)
Measured: Perioperative, 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start19 Jul 2018
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aneurysms Aortic ArchStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertoglio Luca, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600077
- Sponsor's protocol ID
- FETOPT/18/OSR
- Acronym
- FETOPT
- Status last verified
- Nov 2022
- First submitted
- 5 Apr 2018
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Eusanio M, Borger M, Petridis FD, Leontyev S, Pantaleo A, Moz M, Mohr F, Di Bartolomeo R. Conventional versus frozen elephant trunk surgery for extensive disease of the thoracic aorta. J Cardiovasc Med (Hagerstown). 2014 Nov;15(11):803-9. doi: 10.2459/JCM.0b013e328364559c.
PubMed 23867913Hagl C, Pichlmaier M, Khaladj N. Elephant trunks in aortic surgery: fresh and frozen. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S98-102. doi: 10.1016/j.jtcvs.2012.11.065.
PubMed 23410783Bertoglio L, Fittipaldi A, Giambuzzi I, Redaelli P, Verzini A, Cambiaghi T, Bargagna M, Alfieri O, Chiesa R, Castiglioni A. Preliminary Results of Debranch-First Technique in Frozen Elephant Trunk Procedures. Ann Thorac Surg. 2019 Nov;108(5):1345-1353. doi: 10.1016/j.athoracsur.2019.04.010. Epub 2019 May 10.
PubMed 31082360
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Supra-aortic Trunks Debranching Techniques in Open Arch Repair by Means of Frozen Elephant Trunk Procedure With Two Configurations of the Jotec E-Vita Hybrid Graft
- ClinicalTrials.gov ID
- NCT03600077
- Acronym / sponsor ID
- FETOPT / FETOPT/18/OSR
- Conditions
- Aneurysms Aortic Arch
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 26 Jul 2018 (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.
To evaluate two different supra-aortic trunks debranching techniques during open repair of aortic arch aneurysms by means of Frozen Elephant Trunk procedure with two configurations of the Jotec E-Vita hybrid graft.
Detailed description
Open management of extensive pathology of the proximal aorta, namely ascending aorta, aortic arch, and descending thoracic aorta (DTA) requires sequential treatment of each segment involved. According to the etiopathogenesis and clinical history of the disease, each segment can be treated independently or in association with the other portions of diseased aorta.
The current standard of treatment for arch aneurysmal disease extending into the DTA is the elephant trunk technique: both conventional and "frozen". The first requires open repair of the aortic arch with the use of a conventional surgical graft which distal end is left dangling in the DTA and will be the site of the proximal anastomosis of the subsequent repair of the thoracic aneurysm. The frozen elephant trunk (FET) technique differs from the first for the graft employed: this graft has a distal stented portion which is deployed in the DTA and facilitates subsequent endovascular management of the thoracic pathology.
In both the conventional elephant trunk and frozen elephant trunk the supra-aortic trunks (innominate artery, left carotid artery and left subclavian artery) need to be reimplanted on the surgical graft with variable configurations.
Debranching and reimplantation of such vessels can occur with variable configurations and either before or after the substitution of the pathologic aorta which is performed during cardiac arrest and extra-corporeal circulation (ECC) The first design has a straight tubual graft with self-expanding stents in the distal portion and has been employed at department of Vascular Surgery in San Raffaele Hospital, from December 2009 to February 2016. The second design has two side-branches on the non-stented proximal portion which facilitate debranching of the supra-aortic trunks before cardiac arrest and allow early reperfusion of the visceral vessels during extra-corporeal circulation . This graft has been introduced in practice at department of Vascular Surgery at San Raffaele Hospital in November 2016.
The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 30 patients affected by extensive proximal aortic pathology treated at department of Vascular Surgery in San Raffaele Hospital between December 2009 and January 2017 by means of Frozen Elephant Trunk technique, and of those of the next 20 patients who will be treated with the same procedure.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The Investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 30 patients affected by extensive proximal aortic pathology treated at San Raffaele Hospital between December 2009 and January 2017 by means of Frozen Elephant Trunk technique, and of those of the next 20 patients who will be treated with the same procedure.
Key inclusion criteria (1 listed)
- patient undergoing treatment of extensive proximal aortic pathology at San Raffaele Hospital since December 2009
Key exclusion criteria (1 listed)
- extensive proximal aortic pathology treated by techniques other than frozen elephant trunk : total open aortic repair, total endovascular aortic repair, hybrid endovascular aortic repair in zone 0.
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
Extracorporeal circulation times (minutes)
Time frame: Intraoperative
- Extracorporeal circulation time
antegrade cerebral perfusion time (minutes)
Time frame: Intraoperative
- antegrade cerebral perfusion time
Lower limb perfusion time (minutes)
Time frame: Intraoperative
- Lower limb perfusion time
5 secondary outcomes
Clinical 30-day results (Percent of participants with the clinical outcome)
Time frame: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
Time frame: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
Time frame: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
Time frame: Perioperative, 30 days
Clinical 30-day results (Percent of participants with the clinical outcome)
Time frame: Perioperative, 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Results publication: PubMed 23867913Di Eusanio M, Borger M, Petridis FD, Leontyev S, Pantaleo A, Moz M, Mohr F, Di Bartolomeo R. Conventional versus frozen elephant trunk surgery for extensive disease of the thoracic aorta. J Cardiovasc Med (Hagerstown). 2014 Nov;15(11):803-9. doi: 10.2459/JCM.0b013e328364559c.
- Results publication: PubMed 23410783Hagl C, Pichlmaier M, Khaladj N. Elephant trunks in aortic surgery: fresh and frozen. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S98-102. doi: 10.1016/j.jtcvs.2012.11.065.
- Derived from this study: PubMed 31082360Bertoglio L, Fittipaldi A, Giambuzzi I, Redaelli P, Verzini A, Cambiaghi T, Bargagna M, Alfieri O, Chiesa R, Castiglioni A. Preliminary Results of Debranch-First Technique in Frozen Elephant Trunk Procedures. Ann Thorac Surg. 2019 Nov;108(5):1345-1353. doi: 10.1016/j.athoracsur.2019.04.010. Epub 2019 May 10.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneurysms Aortic Arch, run by IRCCS San Raffaele 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 1 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: finished, as of the sponsor's last update on 14 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Extracorporeal circulation times (minutes) (time frame: Intraoperative). The study lists 3 primary outcomes in all. 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 NCT03600077, which also lists 3 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 14 Nov 2022.