Aortic Aneurysm, Abdominal Clinical Trial
Official title:
A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)
NCT number | NCT04930172 |
Other study ID # | TORCH2 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 30, 2022 |
Est. completion date | October 30, 2022 |
Verified date | November 2022 |
Source | IRCCS San Raffaele |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 100 |
Est. completion date | October 30, 2022 |
Est. primary completion date | October 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico S. Orsola Malpighi | Bologna | |
Italy | Azienda Universitaria Giuliano Isontina | Cattinara | |
Italy | Ospedale Policlinico San Martino | Genova | |
Italy | IRCCS Ospedale San Raffaele | Milano | Lombardia |
Italy | Azienda Ospedaliera di Perugia | Perugia | |
Italy | Ospedale San Camillo-Forlanini | Roma | |
Italy | Ospedale San Giovanni Addolorata | Roma |
Lead Sponsor | Collaborator |
---|---|
IRCCS San Raffaele | Azienda Ospedaliero, Universitaria Pisana |
Italy,
Mirza AK, Tenorio ER, Kärkkäinen 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | technical success | successful bridging stent graft deployment of all vessels, with aneurysm exclusion, without any signs of type I or type III endoleak, and with no evidence of stenosis/occlusion and mating stent dislocation/kinking at intraoperative completion angiography. | 30 days | |
Primary | branch instability | freedom from any branch related complications and/or required reinterventions | 30 days | |
Primary | clinical success | absence of death, type I/III endoleak, graft infection/thrombosis, aneurysm expansion and/or rupture, conversion to open repair, or new treatment-related thoracoabdominal pathologies | 30 days |
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