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CompletedNCT04930172Updated Nov 14, 2022

TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

An observational study in Aortic Aneurysm, Abdominal and Aortic Aneurysm, Thoracic, sponsored by IRCCS San Raffaele. Completed at 7 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-14.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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

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Conditions studied

  • Aortic Aneurysm, Abdominal
  • Aortic Aneurysm, Thoracic
03

In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's enrollment of 100 is below the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Steerable introducers

    Device: Steerable introducers

Interventions

  • DeviceSteerable introducers

    endografts via total transfemoral approach for visceral vessels cannulation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 days

  2. branch instability

    freedom from any branch related complications and/or required reinterventions

    Time frame: 30 days

  3. 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

    Time frame: 30 days

07

Study locations

7 sites
  • IRCCS Ospedale San Raffaele
    Milano, Lombardia 20132, Italy
  • Policlinico S. Orsola Malpighi
    Bologna, Italy
  • Azienda Universitaria Giuliano Isontina
    Cattinara, Italy
  • Ospedale Policlinico San Martino
    Genova, Italy
  • Azienda Ospedaliera di Perugia
    Perugia, Italy
  • Ospedale San Camillo-Forlanini
    Roma, Italy
  • Ospedale San Giovanni Addolorata
    Roma, Italy
08

References and documents

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. PubMed 32081482 ↗
  • 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. PubMed 31882309 ↗
  • 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. PubMed 25176618 ↗
  • 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. PubMed 32473341 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04930172
Lead sponsor
IRCCS San Raffaele
Collaborators
Azienda Ospedaliero, Universitaria Pisana
Responsible party
Bertoglio Luca (MD, IRCCS San Raffaele) — Principal investigator
First posted
Jun 18, 2021
Start date
Oct 30, 2022
Primary completion
Oct 30, 2022
Completion
Oct 30, 2022
Last update
Nov 14, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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