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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT03410420
Eligibility Criteria:
Inclusion Criteria:
1. Adults ≥ 18 years of age who require one of the following open surgery:
* Ascending thoracic aorta repair due to aneurysm;
* Aortic valve replacement due to aortic valve insufficiency;
* Coronary artery bypass graft procedure due to coronary heart disease. Imaging CT scans and echography defining the presence of ascending aortic aneurysm will be centrally reviewed prospectively to ensure adherence to subject inclusion criteria.
2. Adequate hematologic functions:
* White blood cells \> 2500/µ;
* Platelets \> 100,000/µL;
* Hemoglobin \> 8 g/dl.
3. Adequate renal functions: serum creatinine \< 2.0 mg/dl.
4. Adequate hepatic function: serum alkaline phosphatase, bilirubin, and serum glutamate oxaloacetate transaminase twice normal levels.
5. If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure.
6. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
7. Female subjects of childbearing potential must have a negative serum pregnancy test at screening. human chorionic gonadotropin levels will be assessed for all women of childbearing years prior to the procedure.
Exclusion Criteria:
1. Severe septicemia or severe infection in the 4 weeks prior to study entry;
2. The subject has a baseline NIHSS \> 1 or modified Rankin Scale \> 1.
3. Active participation in other research therapy for cardiovascular repair/regeneration;
4. Pregnant or breastfeeding at time of screening;
5. Cardiothoracic surgery within 30 days prior to screening;
6. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03410420
Study Brief:
Protocol Section:
NCT03410420