Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome

Recruiting

• Conditions: Acute Aortic Syndrome
• Interventions: Device: the Castor single branch stent graft

• Registration Number: NCT05965453
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (\<15mm)

Detailed Description

The goal of this observational, ambispective, and multicenter cohort study is to evaluate efficacy and safety of the Castor single branch stent graft.

205 patients who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled patients have an inadequate proximal landing zone (\<15mm) , and they underwent routine follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the following, but not limited to assessment: physical examination, laboratory test and the CT angiography.

Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and annually to 10-years post-procedure.

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2023-06
• Study First Submitted: 2023-06-27
• Study First Submitted QC: 2023-07-20
• Last Update Submitted: 2023-07-20
• Study First Posted: 2023-07-28
• Last Update Posted: 2023-07-28
• Primary Completion: 2032-06-01
• Study Completion: 2032-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• Patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022

Exclusion Criteria

• Patients with acute type B aortic syndrome with an adequate proximal landing zone (≥15mm)
• Previous endovascular repair of the aorta
• Patients with missing data and loss of follow-up

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants received thoracic endovascular aortic repair with Castor single branch stent graft	the Castor single branch stent graft	Participants who have an inadequate proximal landing zone received thoracic endovascular aortic repair by meant of the Castor single branch stent graft

Primary Outcome Measures

Name	Time	Method
Immediate post-operative technique success	immediately post operation	Immediate technical success is defined as successful delivery of the aortic and branching stent graft conveyors to their predetermined position, accurate positioning and successful deployment of the stent, safe removal of the delivery device outside the body, absence of Type I and III endoleaks on angiography at the end of the procedure, and patent branch stents.
All-cause mortality and major	1-year post operation	All-cause mortality includes aortic mortality, non-aortic mortality, and mortality from unknown causes.

Secondary Outcome Measures

Name	Time	Method
Aortic remodeling results as assessed by computer tomography angiography (the size of the true and false lumen of aorta, and the thrombosis degree of the false lumen of aorta)	1-month, 6-months, 1-year, and annually to 10-years post operation	Compare the results of computer tomography angiography before operation and on the first-, 6th- and 12th-month post operation, the expansion of the true lumen and the thrombosis of the false lumen at the coverage of the stent graft to determine whether the blood vessel is successfully remodeled
Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography	1-month, 6-months, 1-year, and annually to 10-years post operation	Major device or procedure related major adverse events as assessed by computer tomography angiography included: death, dissection or aneurysm rupture, new myocardial infarction requiring intervention (percutaneous transluminal coronary angioplasty, bypass), retrograde type A aortic dissection, endoleaks, new disabling stroke, paraplegia, new hepatic infarction, new chronic renal insufficiency/renal failure requiring dialysis, lower limb ischemia (increase in Rutherford classification), access vessel thrombosis or rupture, conversion to open surgery, and stent migration, fracture or migration, stent graft infection, stent graft-induced new entry tear.
Re-intervention during follow-up	1-month, 6-months, 1-year, and annually to 10-years post operation	Re-intervention result from device/procedure-related adverse events.

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China