Clinical Scorecard: Results of a Prospective Multicenter Trial on Endovascular Repair of the Aortic Arch Using a Standard Modular Inner Branched Stent-Graft: An IDEAL 2a Study
At a Glance
Category
Detail
Condition
Aortic arch pathologies requiring repair
Key Mechanisms
Endovascular repair using a non-customized modular inner branched stent-graft system to reconstruct the aortic arch
Target Population
Patients with aortic arch pathology deemed high-risk or unsuitable for open surgery
Technical success rate of 100% with the modular inner branched stent-graft system
30-day mortality rate of 3% and stroke rate of 9% post-procedure
Overall survival rates of 91%, 86%, and 81% at 12, 24, and 36 months respectively
Guideline-Based Recommendations
Diagnosis
Multidisciplinary evaluation including vascular surgeon, cardiovascular surgeon, and anesthetist
Imaging with CT angiography pre- and post-procedure at 1, 6, 12 months and annually thereafter
Management
Use of non-customized modular inner branched stent-graft (WeFlow-Arch) for endovascular repair in high-risk or unsuitable open surgery patients
Strict adherence to device instructions for use
Consideration of hybrid or open surgery alternatives based on patient risk and anatomy
Monitoring & Follow-up
Clinical examination and CT angiography follow-up at scheduled intervals (1, 6, 12 months, then annually)
Monitoring for complications such as endoleaks and stroke
Assessment for need of reintervention
Risks
Perioperative stroke (observed 9% rate)
Early mortality (3% within 30 days)
Potential for endoleaks, though none required reintervention in this study
Patient & Prescribing Data
88 patients with aortic arch pathology enrolled from June 2021 to December 2024 across 17 Chinese centers
Modular branched stent-graft repair is feasible with safety outcomes comparable to custom-made devices, hybrid techniques, and open surgery; long-term comparative effectiveness remains to be established
Clinical Best Practices
Perform patient selection via multidisciplinary team assessment focusing on surgical risk and anatomical suitability
Employ modular inner branched stent-graft as an off-the-shelf option to reduce waiting times associated with custom devices
Schedule systematic follow-up with clinical and imaging assessments to detect complications early
Maintain adherence to device-specific procedural protocols to optimize technical success
Consider endovascular repair primarily in patients unfit for open surgery as per expert consensus
