Clinical trial NCT04930172: TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry
Official title: A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Aortic Aneurysm, Thoracic
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero, Universitaria Pisana
First posted: 2021-06-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Registry will include approximately 100 patients treated with BEVAR from January 2018 to January 2022 for thoracoabdominal aortic aneurysms with total transfemoral procedures

Brief summary: The purpose of the registry is to evaluate the peri-operative, short-, and mid- outcomes of endovascular treatment of thoracoabdominal aneurysms with multibranched endografts via total transfemoral approach for visceral vessels cannulation using steerable sheaths


Eligibility criteria: Inclusion Criteria:

* patient adult ( ≥18 years) of either sex,
* patients who underwent a complex aortic procedure requiring a branched endograft via total transfemoral approach in the centers involved in the TORCH2 Registry

Exclusion Criteria:

* patients who did not receive treatment via total transfemoral approach,
* patient with bleeding diathesis or coagulopathy,
* patients with active systemic or cutaneous infection or inflammation,
* patients who are pregnant or lactating,
* patient younger than 18 years of age.
* Absence of at least one imaging follow-up within the first post-operative year

Primary outcomes:
measure: technical success
timeFrame: 30 days
measure: branch instability
timeFrame: 30 days
measure: clinical success
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardia
city: Bologna
country: Italy
facility: Policlinico S. Orsola Malpighi
city: Cattinara
country: Italy
facility: Azienda Universitaria Giuliano Isontina
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia
city: Roma
country: Italy
facility: Ospedale San Camillo-Forlanini
city: Roma
country: Italy
facility: Ospedale San Giovanni Addolorata
Study officials:
References:
citation: Mirza AK, Tenorio ER, Karkkainen JM, Hofer J, Macedo T, Cha S, Ozbek P, Oderich GS. Learning curve of fenestrated and branched endovascular aortic repair for pararenal and thoracoabdominal aneurysms. J Vasc Surg. 2020 Aug;72(2):423-434.e1. doi: 10.1016/j.jvs.2019.09.046. Epub 2020 Feb 17.
citation: Tenorio ER, Oderich GS, Farber MA, Schneider DB, Timaran CH, Schanzer A, Beck AW, Motta F, Sweet MP; U.S. Fenestrated and Branched Aortic Research Consortium Investigators. Outcomes of endovascular repair of chronic postdissection compared with degenerative thoracoabdominal aortic aneurysms using fenestrated-branched stent grafts. J Vasc Surg. 2020 Sep;72(3):822-836.e9. doi: 10.1016/j.jvs.2019.10.091. Epub 2019 Dec 25.
citation: Oikonomou K, Kopp R, Katsargyris A, Pfister K, Verhoeven EL, Kasprzak P. Outcomes of fenestrated/branched endografting in post-dissection thoracoabdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2014 Dec;48(6):641-8. doi: 10.1016/j.ejvs.2014.07.005. Epub 2014 Aug 28.
citation: Motta F, Parodi FE, Knowles M, Crowner JR, Pascarella L, McGinigle KL, Marston WA, Kibbe MR, Ohana E, Farber MA. Performance of Viabahn balloon-expandable stent compared with self-expandable covered stents for branched endovascular aortic repair. J Vasc Surg. 2021 Feb;73(2):410-416.e2. doi: 10.1016/j.jvs.2020.05.028. Epub 2020 May 27.