TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)

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

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Intervention / Treatment: Device: Steerable introducers

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy
    • Policlinico S. Orsola Malpighi
  • Cattinara, Italy
    • Azienda Universitaria Giuliano Isontina
  • Genova, Italy
    • Ospedale Policlinico San Martino
  • Perugia, Italy
    • Azienda Ospedaliera di Perugia
  • Roma, Italy
    • Ospedale San Giovanni Addolorata
  • Roma, Italy
    • Ospedale San Camillo-Forlanini
  • Lombardia
    • Milano, Lombardia, Italy, 20132
      • Irccs Ospedale San Raffaele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Steerable introducers	Device: Steerable introducers; endografts via total transfemoral approach for visceral vessels cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Collaborators: Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): October 30, 2022
• Study Completion (Actual): October 30, 2022

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: TORCH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No