TOtal tRansfemoral branCHed endovasCular tHoracoabdominal Aortic Repair Registry

NCT ID: NCT04930172

Last Updated: 2022-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-30

Study Completion Date

2022-10-30

Brief Summary

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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

Detailed Description

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Conditions

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Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Steerable introducers

Steerable introducers

Intervention Type DEVICE

endografts via total transfemoral approach for visceral vessels cannulation

Interventions

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Steerable introducers

endografts via total transfemoral approach for visceral vessels cannulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role collaborator

IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Bertoglio Luca

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Site Status

Policlinico S. Orsola Malpighi

Bologna, , Italy

Site Status

Azienda Universitaria Giuliano Isontina

Cattinara, , Italy

Site Status

Ospedale Policlinico San Martino

Genova, , Italy

Site Status

Azienda Ospedaliera di Perugia

Perugia, , Italy

Site Status

Ospedale San Camillo-Forlanini

Roma, , Italy

Site Status

Ospedale San Giovanni Addolorata

Roma, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 32081482 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31882309 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25176618 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32473341 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37326371 (View on PubMed)

Other Identifiers

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TORCH2

Identifier Type: -

Identifier Source: org_study_id

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