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New treatment option for Ascending Aortic Dissection
Official title Retrograde Ascending Dissection: Intraluminal Aortic Therapy
ClinicalTrials.gov ID: NCT07405242
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Voluntary participation in the clinical trial; The individual fully understands and is informed of this study and has signed the informed consent...
- 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...
- Evaluation by cardiac surgery indicates that open surgical treatment is not suitable, performing open surgery poses significant risks or the risks...
- Arterial access conditions are permitted, without severe stenosis or distortion, and the stent delivery system can be smoothly introduced;
You likely can't join if
- Severe organ ischemia or functional failure, which, after assessment, is considered to have an extremely poor prognosis and cannot benefit from...
- Planned to undergo aortic valve repair/replacement or coronary artery treatment 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;
See the full eligibility 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...
- 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;
- 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...
- Planned to undergo aortic valve repair/replacement or coronary artery treatment 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 treatment clinical studies;
- Other situations judged by the investigator as not suitable for inclusion in the study;
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.