Thoracoabdominal Aortic AneurysmPAXANCT03223311
"Percutaneous Axillary Access in the Endovascular Treatment of Thoracoabdominal Aortic Pathology" (PAXA)
An observational study of Thoracoabdominal Aortic Aneurysm, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Since the development of custom-made fenestrated and branched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thoracoabdominal Aortic Aneurysm
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 28 Aug 2017to 14 Dec 2020
- 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: patient undergoing total endovascular treatment of thoracoabdominal pathology
Who may be able to join
- Patient undergoing total endovascular treatment of thoracoabdominal pathology at San Raffaele Hospital in between October 2013 and December 2020.
Who cannot join
- Incomplete imaging quality not including the arterial segments to be studied (axillary and brachial artery).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Percutaneous Axillary Access in the Endovascular Treatment of Thoracoabdominal Aortic Pathology"
Since the development of custom-made fenestrated and branched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. Because of the design of these branched endografts, an arterial vascular access from the upper limb is required to allow selective catheterization of the branch component and the respective target vessel (celiac trunk, superior mesenteric artery, renal artery).2
Read the detailed description
Primary end-point is to evaluate the requirement of upper extremity arterial access (UEA) retrospectively in the cohort of patients with thoracoabdominal aortic aneurysms treated by means fenestrated and/or branched endografts in Vascular surgery San Raffaele Hospital between 2013 and 2017, and prospectively in the next 50 patients that will be treated between 2017 and 2020.
Secondary end-point is an anatomical evaluation of the different sites available for UEA(upper extremity arterial access ) based on pre-operative imaging studies.
Materials and methods:
The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 34 patients treated at Vascular surgery of San Raffaele Hospital between October 2013 and March 2017 by means of total endovascular thoracoabdominal aortic aneurysm repair and of those of the next 50 patients who will be treated until December 2020. All patients in which an UAE (upper extremity arterial access ) is employed will be identified together with the side (left/right) and site (proximal/distal axillary artery, brachial artery) of vascular access. Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed at Vascular surgery of San Raffaele Hospital for imaging assessment.
Requirement of an UEA(upper extremity arterial access ) during the procedure is extrapolated from the corresponding field of the available database and reported together with side and site of access and reason for the employment of UEA (upper extremity arterial access ) and for its location.
Multi-planar, curved and 3D reconstructions of each patient CTA will be analyzed and the following measurements recorded:
- patency of both potential upper extremity access vessels (right/left subclavian artery);
- diameter of the proximal axillary artery on both sides;
- diameter of the distal axillary artery on both sides;
- presence of calcifications on the proximal axillary artery on both sides;
- presence of calcifications on the distal axillary artery on both sides;
- arterial tortuosity index on both sides: measured as the ratio between the axillary artery length measured on curved reconstruction and its length measured on 3D reconstruction.
All the assessed variables will be prospectively recorded in a Microsoft Office Excel database together with patients' weight, height, age and gender.
All patients involved in the retrospective part of the study have already signed informed consent for data collection and analysis at hospital admission.
The 50 patients that will be enrolled until December 2020 will also sign an "ad hoc" consents, specific for this study.
Sensitive patient information will not be available during data analysis. The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies.
Analysis:
Patients characteristics and anatomical data on UEAs(upper extremity arterial access) will be analyzed on Wizard Statistics software to investigate the presence of statistically significant Pearson correlations among the identified variables.
The extracted data and their relevant clinical and procedural implications will be submitted for publication in peer-reviewed scientific journals focused on the field of vascular and endovascular surgery.
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Medical subject headings
- Aortic Aneurysm, Thoracoabdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of upper extremity access in endovascular repair of thoracoabdominal aortic aneurysms
- Endovascular graft design : branched / fenestrated
- Employment of UEA(upper extremity arterial access ) during TAAA endovascular repair: yes / no
- Side of UEA(upper extremity arterial access ) cannulation (left / right)
- Site of UEA(upper extremity arterial access ) cannulation:proximal axillary artery / distal axillary artery / upper brachial artery.
- Size of percutaneuos access sheath employed measured in French - Fr
- Number of percutaneuos access vessel closure devices employed
- Access closure specific outcome: primary success / secondary success / failure As reported on patients' charts and operative report
Measured: between 2013 and 2020
Secondary outcomes (1)
Upper extremity access vascular anatomy
- UEA(upper extremity arterial access ) vessel patency: yes / no
- Diameter of proximal axillary artery measured in Millimeters ( mm)
- Diameter of distal axillary artery measured in Millimeters (mm)
- Presence of calcifications at UEA(upper extremity arterial access ): none / < 50% / > 50%.
- Tortuosity index reported as bare number, defined as the ratio between the axillary artery length measured on curved centerline reconstruction and its length measured on 3D reconstruction.
As measured at preoperative contrast-enhanced CT scan
Measured: between 2013 and 2017.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start28 Aug 2017
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
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 Thoracoabdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- 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
- Investigators
- Luca Bertoglio, MD, Principal investigator, SAn Raffaele Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223311
- Sponsor's protocol ID
- PAXA/31/OSR
- Acronym
- PAXA
- Status last verified
- Dec 2020
- First submitted
- 7 Jul 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alvarez-Tostado JA, Moise MA, Bena JF, Pavkov ML, Greenberg RK, Clair DG, Kashyap VS. The brachial artery: a critical access for endovascular procedures. J Vasc Surg. 2009 Feb;49(2):378-85; discussion 385. doi: 10.1016/j.jvs.2008.09.017. Epub 2008 Nov 22.
PubMed 19028057Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.
PubMed 17980540Bertoglio L, Grandi A, Melloni A, Kahlberg A, Melissano G, Chiesa R. Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):929-938. doi: 10.1016/j.ejvs.2020.01.027. Epub 2020 Feb 20.
PubMed 32089506Bertoglio L, Mascia D, Cambiaghi T, Kahlberg A, Melissano G, Chiesa R. Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair. J Vasc Surg. 2018 Jul;68(1):12-23. doi: 10.1016/j.jvs.2017.09.053. Epub 2018 Mar 1.
PubMed 29503006
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Percutaneous Axillary Access in the Endovascular Treatment of Thoracoabdominal Aortic Pathology"
- ClinicalTrials.gov ID
- NCT03223311
- Acronym / sponsor ID
- PAXA / PAXA/31/OSR
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 21 Jul 2017 (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.
Since the development of custom-made fenestrated and branched endografts a novel therapeutic option for the management of thoracoabdominal and para-renal aortic aneurysms was made accessible. Because of the design of these branched endografts, an arterial vascular access from the upper limb is required to allow selective catheterization of the branch component and the respective target vessel (celiac trunk, superior mesenteric artery, renal artery).2
Detailed description
Primary end-point is to evaluate the requirement of upper extremity arterial access (UEA) retrospectively in the cohort of patients with thoracoabdominal aortic aneurysms treated by means fenestrated and/or branched endografts in Vascular surgery San Raffaele Hospital between 2013 and 2017, and prospectively in the next 50 patients that will be treated between 2017 and 2020.
Secondary end-point is an anatomical evaluation of the different sites available for UEA(upper extremity arterial access ) based on pre-operative imaging studies.
Materials and methods:
The investigators review a prospectively compiled Microsoft Office Excel database with the procedural details of the 34 patients treated at Vascular surgery of San Raffaele Hospital between October 2013 and March 2017 by means of total endovascular thoracoabdominal aortic aneurysm repair and of those of the next 50 patients who will be treated until December 2020. All patients in which an UAE (upper extremity arterial access ) is employed will be identified together with the side (left/right) and site (proximal/distal axillary artery, brachial artery) of vascular access. Furthermore, the pre-operative contrast-enhanced computed tomography scans (CTA) of all patients, stored in the hospital PACS, will be analyzed on the dedicated workstation with OsiriX software (Pixmeo sarl, Bernex, Switzerland) currently employed at Vascular surgery of San Raffaele Hospital for imaging assessment.
Requirement of an UEA(upper extremity arterial access ) during the procedure is extrapolated from the corresponding field of the available database and reported together with side and site of access and reason for the employment of UEA (upper extremity arterial access ) and for its location.
Multi-planar, curved and 3D reconstructions of each patient CTA will be analyzed and the following measurements recorded:
- patency of both potential upper extremity access vessels (right/left subclavian artery);
- diameter of the proximal axillary artery on both sides;
- diameter of the distal axillary artery on both sides;
- presence of calcifications on the proximal axillary artery on both sides;
- presence of calcifications on the distal axillary artery on both sides;
- arterial tortuosity index on both sides: measured as the ratio between the axillary artery length measured on curved reconstruction and its length measured on 3D reconstruction.
All the assessed variables will be prospectively recorded in a Microsoft Office Excel database together with patients' weight, height, age and gender.
All patients involved in the retrospective part of the study have already signed informed consent for data collection and analysis at hospital admission.
The 50 patients that will be enrolled until December 2020 will also sign an "ad hoc" consents, specific for this study.
Sensitive patient information will not be available during data analysis. The clinical study will be carried out according to the ethical principles of the Declaration of Helsinki and following the active regulations on observational studies.
Analysis:
Patients characteristics and anatomical data on UEAs(upper extremity arterial access) will be analyzed on Wizard Statistics software to investigate the presence of statistically significant Pearson correlations among the identified variables.
The extracted data and their relevant clinical and procedural implications will be submitted for publication in peer-reviewed scientific journals focused on the field of vascular and endovascular surgery.
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
- patient undergoing total endovascular treatment of thoracoabdominal pathology
Key inclusion criteria (1 listed)
- Patient undergoing total endovascular treatment of thoracoabdominal pathology at San Raffaele Hospital in between October 2013 and December 2020.
Key exclusion criteria (1 listed)
- Incomplete imaging quality not including the arterial segments to be studied (axillary and brachial artery).
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
Use of upper extremity access in endovascular repair of thoracoabdominal aortic aneurysms
Time frame: between 2013 and 2020
* Endovascular graft design : branched / fenestrated * Employment of UEA(upper extremity arterial access ) during TAAA endovascular repair: yes / no * Side of UEA(upper extremity arterial access ) cannulation (left / right) * Site of UEA(upper extremity arterial access ) cannulation:proximal axillary artery / distal axillary artery / upper brachial artery. * Size of percutaneuos access sheath employed measured in French - Fr * Number of percutaneuos access vessel closure devices employed * Access closure specific outcome: primary success / secondary success / failure As reported on patients' charts and operative report
1 secondary outcome
Upper extremity access vascular anatomy
Time frame: between 2013 and 2017.
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 16 Dec 2020.
- Results publication: PubMed 19028057Alvarez-Tostado JA, Moise MA, Bena JF, Pavkov ML, Greenberg RK, Clair DG, Kashyap VS. The brachial artery: a critical access for endovascular procedures. J Vasc Surg. 2009 Feb;49(2):378-85; discussion 385. doi: 10.1016/j.jvs.2008.09.017. Epub 2008 Nov 22.
- Results publication: PubMed 17980540Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, Reilly LM. Endovascular treatment of thoracoabdominal aortic aneurysms. J Vasc Surg. 2008 Jan;47(1):6-16. doi: 10.1016/j.jvs.2007.08.032. Epub 2007 Nov 5.
- Derived from this study: PubMed 32089506Bertoglio L, Grandi A, Melloni A, Kahlberg A, Melissano G, Chiesa R. Percutaneous AXillary Artery (PAXA) Access at the First Segment During Fenestrated and Branched Endovascular Aortic Procedures. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):929-938. doi: 10.1016/j.ejvs.2020.01.027. Epub 2020 Feb 20.
- Derived from this study: PubMed 29503006Bertoglio L, Mascia D, Cambiaghi T, Kahlberg A, Melissano G, Chiesa R. Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair. J Vasc Surg. 2018 Jul;68(1):12-23. doi: 10.1016/j.jvs.2017.09.053. Epub 2018 Mar 1.
- 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.
Luca Bertoglio, MD principal investigator
SAn Raffaele Hospital
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 Thoracoabdominal Aortic Aneurysm, 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 16 Dec 2020. 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?
Use of upper extremity access in endovascular repair of thoracoabdominal aortic aneurysms (time frame: between 2013 and 2020). 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 NCT03223311, 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 16 Dec 2020.