Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2022
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Steerable introducers
endografts via total transfemoral approach for visceral vessels cannulation

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
IRCCS San Raffaele Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT03657979 - TAP-Block in Abdominal Aortic Surgery Phase 4
Enrolling by invitation NCT01465425 - Extracolonic Findings on Computed Tomography (CT) Colonography
Completed NCT02845167 - Effect of Preoperative Exercise on Postoperative Outcome in AAA Patients: Pilot Study N/A
Not yet recruiting NCT00358085 - NExT ERA: National Expertise Based Trial of Elective Repair of Abdominal Aortic Aneurysms: A Pilot Study Phase 3
Terminated NCT00118573 - Comparison of Surveillance Versus Aortic Endografting for Small Aneurysm Repair Phase 4
Completed NCT04792411 - Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery N/A
Withdrawn NCT02995642 - Targeted PET/CT and PET/MRI Imaging of Vascular Inflammation Phase 2
Completed NCT01980901 - Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
Active, not recruiting NCT01698671 - InterGard Synergy Post-Marketing Surveillance Study N/A
Enrolling by invitation NCT00831870 - EndoSure Sensor for Long-term Follow-up After Endovascular AAA Repair N/A
Recruiting NCT05972018 - Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters Phase 4
Not yet recruiting NCT02997618 - The AAA Get Fit Trial: A Pilot Randomised Controlled Trial of Community Based Exercise in Patients With Abdominal Aortic Aneurysms N/A
Active, not recruiting NCT02907762 - Aorfix Intelliflex First in Human Study
Completed NCT00349947 - Exercise Therapy to Treat Adults With Abdominal Aortic Aneurysms Phase 1
Completed NCT04080557 - Abdominal Aortic Aneurysm Patients Remain at Risk for Delirium on the Surgical Ward After Intensive Care Unit Dismissal
Recruiting NCT05484115 - Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck N/A
Recruiting NCT04503395 - ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES N/A
Completed NCT02867501 - Venous Distension in Patients With Aneurysmatic Arterial Disease N/A
Recruiting NCT02345590 - Eplerenone in the Management of Abdominal Aortic Aneurysms Phase 4
Recruiting NCT01985906 - Safety and Efficacy of Multiple Overlapping Uncovered Stents for Pararenal Aortic Aneurysm Repair N/A