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 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT00985634
Eligibility Criteria:
Inclusion Criteria:
1. Subjects undergoing elective off pump coronary artery bypass (OPCAB) surgery where the surgeon prospectively plans to use a vascular occlusion device.
2. \>70% proximal stenosis of at least one target coronary artery, other than left main
3. Age: between the ages 18 -79 years
4. Gender: male and female
5. Subject is willing and able to participate in a clinical research study and provides informed consent.
6. Subject is able and willing to participate in required follow-up procedures.
Exclusion Criteria:
1. Previous cardiac surgery.
2. Left ventricular dysfunction (EF \<40%)
3. \>50% of left main coronary artery stenosis
4. Subjects with a logistic EuroScore equal to or greater than 10% as calculated by the euroscore.org calculator
5. Emergent Surgery: Subjects undergoing surgery before the start of the next working day following catheterization
6. Creatinine \> 200 µmol/L
7. Bilirubin \> 21 µmol/L
8. Subjects with chronic pulmonary disease \[ FEV1 \< 45% \]
9. Any subject who is deemed by the investigator, for any reason, not suitable or able to participate in a clinical research study.
10. Pregnant women. Women of childbearing age will require a pregnancy test within 10 days of the operation and will be excluded if the result is positive.
11. Women who are lactating.
12. Subjects who have undergone other investigational therapy within 30 days prior to the operation or who are scheduled to receive investigational therapy within six months of the operation.
13. Subjects suspected to have one intra-myocardial artery among the coronary arteries to be bypassed during that surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00985634
Study Brief:
Protocol Section:
NCT00985634