Ascending Aortic DissectionRADIALNCT07405242
Retrograde Ascending Dissection: Intraluminal Aortic Therapy
A study testing Endovascular treatment of aortic dissection (stent implantation) in people with Ascending Aortic Dissection, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ascending Aortic Dissection
- What is being tested?
- Endovascular treatment of aortic dissection (stent implantation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 12Show fewer
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University Medical School Affiliated Ruijing Hospital
Shanghai, Shanghai Municipality, 201801
Junyi Yan, 13480161737, yanjy0117@gmail.com
About this study
Official title: 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.
- Conditions
- Ascending Aortic Dissection
- Being tested
- Endovascular treatment of aortic dissection (stent implantation)
- Medical subject headings
- Dissection, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular treatment of aortic dissection (stent implantation)Device
Endovascular treatment of aortic dissection (stent implantation)
| Study group | Role | What they receive |
|---|---|---|
| Endovascular treatment of aortic dissection (stent implantation) | Experimental | Not described Receives: Device: Endovascular treatment of aortic dissection (stent implantation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (8)
The incidence rate of surgery-related complications
Measured: 12 months
Success rate of one-year stent implantation technique
Measured: 12 months
The all-cause mortality rates for 6 months and 12 months
Measured: 12 months
The incidence rates of major adverse cardiovascular and cerebrovascular events within 6 months and 12 months
Measured: 12 months
The rates of re-intervention for aortic dissection within 6 months and 12 months
Measured: 12 months
The incidence rates of complications related to aortic dissection for 6 months and 12 months
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405242
- Sponsor's protocol ID
- RX-2025-004
- Acronym
- RADIAL
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07405242
- Acronym / sponsor ID
- RADIAL / RX-2025-004
- Conditions
- Ascending Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endovascular treatment of aortic dissection (stent implantation) | Experimental | Device: Endovascular treatment of aortic dissection (stent implantation) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (12 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endovascular treatment of aortic dissection (stent implantation)Endovascular treatment of aortic dissection (stent implantation) | Device | Endovascular treatment of aortic dissection (stent implantation) |
Primary outcome
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
Time frame: 30 days
8 secondary outcomes
The incidence rate of surgery-related complications
Time frame: 12 months
Success rate of one-year stent implantation technique
Time frame: 12 months
The all-cause mortality rates for 6 months and 12 months
Time frame: 12 months
The incidence rates of major adverse cardiovascular and cerebrovascular events within 6 months and 12 months
Time frame: 12 months
The rates of re-intervention for aortic dissection within 6 months and 12 months
Time frame: 12 months
The incidence rates of complications related to aortic dissection for 6 months and 12 months
Time frame: 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
Time frame: 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.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes
Related trials for Ascending Aortic Dissection
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
RecruitingObservational study
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
Aneurysm, Dissection
Enrolling by invitation
Evaluation of the GORE® Ascending Stent Graft
Aortic Aneurysm, Thoracic, Pseudoaneurysm
Enrolling by invitation
Optimal Strategy for Repair of Type A Acute Aortic Dissection
Aortic Dissection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endovascular treatment of aortic dissection (stent implantation) in people with Ascending Aortic Dissection, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junyi Yan, M.D. (+8613480161737, yanjy0117@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.