West China Hospital Completes World's First Enrollment in the REFORM-TAD Trial for Aortic Dissection

Global Milestone in Cardiovascular Surgery

The international multicenter REFORM-TAD clinical trial, led by Dr. Jia Hu from the Department of Cardiovascular Surgery at West China Hospital, Sichuan University, has successfully completed the world’s first patient enrollment.

This trial will be conducted across 16 leading vascular centers in mainland China, Taiwan, and Europe, marking a significant step forward in cardiovascular research.

The Clinical Challenge: Distal Residual Dissection

REFORM-TAD focuses on a critical, long-standing challenge in the management of Stanford type A aortic dissection.

While emergency open surgery (such as total arch replacement and frozen elephant trunk implantation) effectively treats the proximal aorta and saves lives, some patients are left with distal residual dissection. In high-risk patients, several factors can lead to progressive distal aortic enlargement:

Persistent entry tears
A dominant, non-thrombosed false lumen
True lumen compression
False-lumen-dependent branch perfusion
Currently, the standard management for these patients relies heavily on medical therapy and imaging surveillance. However, if the distal aorta continues to enlarge, patients often face complex secondary open surgeries, which are highly invasive and carry significant procedural risks.

The REFORM-TAD Approach: Early Intervention

The REFORM-TAD trial explores a proactive solution: early endovascular intervention.

By evaluating a novel endovascular reconstruction system designed specifically for this condition, the trial investigates whether early intervention can promote distal true lumen expansion, false lumen reduction, and thrombosis. Ultimately, the goal is to support favorable aortic remodeling and reduce the need for future high-risk reinterventions.

Success of the First Enrolled Case

The first enrolled patient was a 60-year-old male. Following his prior type A repair, imaging revealed residual dissection involving the descending thoracic aorta, abdominal aorta, and iliac arteries, accompanied by true lumen compression and multiple intimal tears.

After individualized imaging analysis and precise procedural planning, Dr. Hu’s team successfully implanted the novel endovascular reconstruction system.

Immediate postoperative angiography confirmed the procedure's success, showing effective coverage of the entry tear, no further visualization of the proximal false lumen, and excellent expansion of the distal true lumen.

Looking Forward: Advancing Evidence-Based Medicine

Currently, there is no approved stent system specifically indicated for this complex condition, and high-quality randomized evidence remains scarce.

This first successful enrollment is more than just a procedural milestone. It highlights West China Hospital’s dedication to advancing type A aortic dissection management—transitioning from technical innovation to rigorous, international, multicenter, evidence-based clinical research. The REFORM-TAD trial holds the promise of establishing safer, more effective minimally invasive treatment standards for high-risk patients worldwide.