Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT05883592
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years old, regardless of gender;
2. Fabulous thoracic aortic stent System is suitable for the treatment of acute or subacute Stanford type B dissection, and the lesions meet one of the following criteria:
1. It is necessary to treat distal lesions due to the presence of distal tears;
2. The dissection involved a wide range, and there was collapse of the distal true cavity;
3. Dissection combined with poor perfusion of distal branch vessels.
3. With appropriate arterial access and suitable for endovascular aortic repair;
4. Subjects could understand the purpose of the trial, volunteered to participate in the study, signed the informed consent form by themselves or their legal representatives, and were willing to complete the follow-up as required by the protocol.
Exclusion Criteria:
1. Patients have participated in clinical trials of other drugs or medical devices related to target lesion treatment or have participated in clinical trials of other drugs or medical devices and have not reached the primary endpoint;
2. Patients were unable or unwilling to participate in the study;
3. Patients were judged by the investigator to be ineligible for participation in the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05883592
Study Brief:
Protocol Section:
NCT05883592