World's First Patient Enrolled! West China Hospital Cardiac and Great Vessel Surgeon Leads International Multicenter Type A Dissection Trial

Background

Stanford type A aortic dissection is a life-threatening condition involving a tear in the inner layer of the aorta in the segment arising from the heart. Blood flows into the aortic wall, creating a false lumen parallel to the true lumen. Emergency open surgical repair is the standard treatment, frequently involving replacement of the ascending aorta and aortic arch combined with implantation of a frozen elephant trunk (FET) stent graft into the proximal descending aorta. This addresses the proximal pathology but leaves many patients with residual dissection beyond the FET stent.

In high-risk cases, the residual distal dissection can feature a narrowed true lumen, enlarged false lumen, multiple entry tears in the thoracoabdominal aorta, and false-lumen perfusion of intercostal and visceral arteries. Such anatomy raises the risk of progressive aortic dilatation, aneurysm formation, or rupture. Reintervention has traditionally involved high-risk open surgery or suboptimal medical management and surveillance. No stent system had been specifically approved for this indication, and high-quality randomized evidence comparing early endovascular intervention to standard care was lacking prior to the initiation of dedicated trials.

What was achieved

On April 17, 2026, West China Hospital of Sichuan University announced completion of enrollment of the world's first subject in the REFORM-TAD trial. The international multicenter prospective randomized controlled trial is led by Hu Jia, director physician in the hospital's Department of Cardiac and Great Vessel Surgery. The study is planned across 16 vascular centers in mainland China, Taiwan, and Europe and aims to enroll 198 patients randomized 1:1 to the novel stent system plus standard medical therapy versus standard care alone.

The first patient was a 60-year-old male who had undergone open repair approximately one month earlier at the hospital for acute Stanford type A aortic dissection. That index operation included aortic valve commissure suspension, ascending aorta and total arch replacement, descending aorta elephant trunk stent implantation, and tricuspid valve plasty. One-month follow-up CTA demonstrated residual dissection distal to the elephant trunk stent extending through the thoracic descending aorta, abdominal aorta, right common and external iliac arteries, with true lumen narrowing, false lumen enlargement, multiple thoracoabdominal entry tears, and predominant false-lumen perfusion of thoracic intercostal arteries.

On the enrollment date, Hu Jia's team performed the endovascular procedure after detailed imaging review and simulation. The patient was discharged on postoperative day 3. One-month follow-up was reported as uneventful. The trial, registered as NCT07402252 with West China Hospital as sponsor and Jia Hu as responsible party, will assess the safety and effectiveness of the Type A Dissection Total Endovascular Reconstruction System in promoting favorable distal aortic remodeling.

How it works

Following the initial open repair with frozen elephant trunk, residual distal dissection persists when tears beyond the stent graft continue to pressurize the false lumen. Over time this can prevent aortic healing. The REFORM-TAD intervention uses a specialized endovascular stent system delivered via femoral access under imaging guidance. The device is a covered stent graft with bare extensions, sized in the first case with a 30 mm proximal diameter, 24 mm distal diameter, overall length of 290 mm, and 120 mm covered segment.

The stent is positioned with its proximal end anchored inside the existing elephant trunk graft and its distal end landed in the infrarenal abdominal aorta. Deployment covers the primary proximal entry tear of the residual thoracic dissection. This redirects flow into the true lumen, promotes thrombosis of the false lumen in the thoracic segment, allows true lumen expansion, and encourages positive remodeling of the distal aorta. The procedure is minimally invasive compared with repeat open thoracotomy or thoracoabdominal surgery, aiming to reduce the need for later high-risk reoperations while being evaluated for safety in the randomized trial setting.

What it means for international patients

West China Hospital maintains an International Medical Center that serves as a designated site for foreign patients by the hospital and Sichuan provincial government. The center provides English-language reception and hospitalization services, international consultation and referral coordination, and works with more than 20 domestic and foreign insurance companies and assistance agencies for appointment and payment processing. It includes dedicated VIP outpatient and inpatient facilities.

International patients with a history of repaired type A aortic dissection and residual distal disease may inquire about participation in ongoing trials or access to advanced aortic therapies at the center. Eligibility for the REFORM-TAD trial or any specific intervention depends on strict inclusion and exclusion criteria, anatomic suitability confirmed by imaging, and current trial status. Patients should contact the International Medical Center directly via the hospital's published channels to submit medical records, obtain case coordination, and confirm availability and suitability for their individual situation.

About the hospital

West China Hospital of Sichuan University is located in Chengdu, the capital of Sichuan Province in southwest China. Founded in 1892, it is a public Grade III, Class A comprehensive teaching hospital directly affiliated with Sichuan University. It operates multiple campuses including the main Huaxiba site and is among China's largest medical facilities.

The hospital is recognized for its clinical volume, research output, and specialist training. In the Nature Index rankings covering the period June 2025 to May 2026, it placed first among Chinese medical institutions and seventh globally. It has maintained top positions in national science and technology evaluations of tertiary hospitals. The Department of Cardiac and Great Vessel Surgery, established in the 1950s, performs approximately 3,600 cardiovascular operations annually and has introduced multiple first-in-kind minimally invasive aortic and valve procedures. The hospital's International Medical Center offers coordinated care for overseas patients across numerous specialties.