A Physician-initiated, National, Multicentre, Ambispective, Observational Registry of Patients Undergoing Branched Endovascular Aortic Procedures With a Total Transfemoral Approach. (TORCH2 Registry)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Aneurysm, Abdominal
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 100
- Locations
- 7
- Primary Endpoint
- technical success
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Bertoglio Luca
MD
IRCCS San Raffaele
Eligibility Criteria
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
Outcomes
Primary Outcomes
technical success
Time Frame: 30 days
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.
branch instability
Time Frame: 30 days
freedom from any branch related complications and/or required reinterventions
clinical success
Time Frame: 30 days
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