TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

NCT04930172 | Completed

• 1 other identifier: TORCH2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 7

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

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (3)

• 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

• branch instability

  freedom from any branch related complications and/or required reinterventions

  30 days

• 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

Study Arms (1)

Steerable introducers

Device: Steerable introducers

Interventions

Steerable introducers DEVICE

endografts via total transfemoral approach for visceral vessels cannulation

Steerable introducers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (7)

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Policlinico S. Orsola Malpighi

Bologna, Italy

Location

Azienda Universitaria Giuliano Isontina

Cattinara, Italy

Location

Ospedale Policlinico San Martino

Genova, Italy

Location

Azienda Ospedaliera di Perugia

Perugia, Italy

Location

Ospedale San Camillo-Forlanini

Roma, Italy

Location

Ospedale San Giovanni Addolorata

Roma, Italy

Location

Related Publications (5)

• 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.

  PMID: 32081482 BACKGROUND

• 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.

  PMID: 31882309 BACKGROUND

• 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.

  PMID: 25176618 BACKGROUND

• 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.

  PMID: 32473341 BACKGROUND

• Mario D, Alessandro G, Giovanni P, Gianbattista P, Rocco G, Mauro G, Nicola M, Roberto C, Sandro L, Luca B; TORCH2 Collaborative Study Group. Total Transfemoral Branched Endovascular Thoracoabdominal Aortic Repair (TORCH2): Short-term and 1-Year Outcomes From a National Multicenter Registry. J Endovasc Ther. 2025 Apr;32(2):513-523. doi: 10.1177/15266028231179864. Epub 2023 Jun 16.

  PMID: 37326371 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 18, 2021
• Study Start: October 30, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

IT (7)