Retrograde Ascending Dissection: Intraluminal Aortic Therapy

NCT07405242 | Recruiting

• 1 other identifier: RX-2025-004
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ascending Aortic Dissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (1)

Endovascular treatment of aortic dissection (stent implantation)

EXPERIMENTAL

Device: Endovascular treatment of aortic dissection (stent implantation)

Interventions

Endovascular treatment of aortic dissection (stent implantation) DEVICE

Endovascular treatment of aortic dissection (stent implantation)

Endovascular treatment of aortic dissection (stent implantation)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital

Shanghai, Shanghai Municipality, 201801, China

RECRUITING

MeSH Terms

Conditions

Dissection, Ascending Aorta

Condition Hierarchy (Ancestors)

Dissection, Thoracic Aorta; Aortic Dissection; Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Central Study Contacts

Junyi Yan, M.D.

CONTACT

+8613480161737; yanjy0117@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CN (1)