Retrograde Ascending Dissection: Intraluminal Aortic Therapy (RADIAL)

A Single-arm, Open-label, Multicenter Clinical Study Evaluating the Safety and Efficacy of Endovascular Treatment for Retrograde Dissections Involving the Ascending Aorta That Are Not Suitable for Open Surgery. （RADIAL)

This study is a single-arm, open-label, multi-center clinical trial evaluating the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta that is not suitable for open surgery. The aim is to assess the short-term (30 days) and medium- to long-term (6 months and 12 months) safety and efficacy of endovascular treatment in patients with retrograde dissection involving the ascending aorta who are not suitable for open surgery. The study plans to include patients with dissection confirmed by imaging, with the tear located in the aortic arch or descending aorta and extending retrogradely to the ascending aorta, and the most distal segment of the dissection is at least 2 cm away from the coronary artery ostia. These patients have been evaluated by cardiac surgery and found to be unsuitable for open surgery, with significant risks or risks outweighing benefits associated with open surgery. This is a single-arm, open-label, multi-center study, and no blinding or randomization will be used, nor will stratification factors be set. After successful screening, the subjects will undergo endovascular treatment for aortic dissection (stent implantation) during the operation. The subjects will be followed up for one year after the operation, and the safety and efficacy of endovascular treatment for retrograde dissection involving the ascending aorta will be evaluated based on the subjects' survival status, the occurrence of surgery and disease-related complications, and the recovery of the disease.

Study Overview

• Status: Recruiting
• Conditions: Ascending Aortic Dissection
• Intervention / Treatment: Device: Endovascular treatment of aortic dissection (stent implantation)

• Study Type: Interventional
• Enrollment (Estimated): 149
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junyi Yan, M.D.; Phone Number: +8613480161737; Email: yanjy0117@gmail.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201801
      • Recruiting
      • Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
      • Contact: Junyi Yan; Phone Number: 13480161737; Email: yanjy0117@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Voluntary participation in the clinical trial; The individual fully understands and is informed of this study and has signed the informed consent form; Willing to follow and be able to complete all trial procedures
• Age ≥ 65 years old, both male and female are eligible
• Confirmed by imaging to be retrograde tear aortic dissection, that is, the tear site is located at the aortic arch or descending aorta, and the retrograde tear involves the ascending aorta. The farthest segment of the dissection tear is ≥ 2 cm from the coronary artery outlet
• Evaluation by cardiac surgery indicates that open surgical treatment is not suitable, performing open surgery poses significant risks or the risks outweigh the benefits
• Arterial access conditions are permitted, without severe stenosis or distortion, and the stent delivery system can be smoothly introduced;

Exclusion Criteria:

• Severe organ ischemia or functional failure, which, after assessment, is considered to have an extremely poor prognosis and cannot benefit from endovascular treatment, such as extensive cerebral infarction or cerebral hemorrhage, resulting in irreversible severe neurological deficits, acute extensive ischemic necrosis of the mesenteric arteries, acute liver and kidney failure;
• Planned to undergo aortic valve repair/replacement or coronary artery interventional therapy within 30 days;
• Mechanical heart valve present at the aortic valve position;
• Aortic valve regurgitation degree ≥ 3+ or 4+;
• Known severe allergy to contrast agents or stent materials (such as nickel-titanium alloys, polyester, etc.);
• Severe systemic infection that may lead to infection after stent implantation;
• Severe coagulation dysfunction, which, after correction, still cannot meet the surgical requirements, or has bleeding tendencies;
• Complicated with other serious diseases or malignant tumors, with a predicted survival period of less than 12 months;
• Pregnant or lactating women;
• With mental illness or cognitive impairment, unable to understand and cooperate with the study;
• Already participating in other ongoing interventional clinical studies;
• Other situations judged by the investigator as not suitable for inclusion in the study;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endovascular treatment of aortic dissection (stent implantation)	Device: Endovascular treatment of aortic dissection (stent implantation); Endovascular treatment of aortic dissection (stent implantation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The death events and major adverse cardiovascular and cerebrovascular events (MACCE) caused by any reason within 30 days after endovascular treatment, as well as their incidence rates	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence rate of surgery-related complications	12 months
Success rate of one-year stent implantation technique	12 months
The all-cause mortality rates for 6 months and 12 months	12 months
The incidence rates of major adverse cardiovascular and cerebrovascular events within 6 months and 12 months	12 months
The rates of re-intervention for aortic dissection within 6 months and 12 months	12 months
The incidence rates of complications related to aortic dissection for 6 months and 12 months	12 months
Aortic imaging remodeling assessment: Changes in the true lumen diameters of the ascending aorta, aortic arch, and descending aorta at 6 months and 12 months after surgery, and the proportion of false lumen reduction or complete thrombosis	12 months
Quality of life assessment: The SF-36 scale was used to evaluate the patients' quality of life scores before the surgery, 6 months after the surgery, and 12 months after the surgery.	12 months

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Dissection, Thoracic Aorta; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection; Dissection, Ascending Aorta
• Other Study ID Numbers: RX-2025-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No