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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT01478061
Eligibility Criteria:
Inclusion Criteria:
* Able to give informed consent.
* Willing and able to have follow-up visits and examinations.
* Less than 80 years old.
* Have an ejection fraction of \>30 %.
* Have a life expectancy of \>1 year.
Pre-Operative Exclusion Criteria:
* Currently participating in other clinical trials that would conflict with this protocol.
* Unable to meet study requirements.
* Currently pregnant.
* Require preoperative use of an intraaortic balloon pump.
* Have a history of a bleeding disorder or history of a thromboembolic disease requiring anticoagulation therapy.
* Have congestive heart failure or been classified as NYHA Class IV.
* Have an aspirin allergy or other contraindications to aspirin use.
* Previous coronary artery bypass surgery.
* Vasculitis or other nonatherosclerotic cause for coronary artery disease.
Intra-Operative Exclusion Criteria:
* At least one target vessel site where the C-Port anastomosis will be placed that is free from severe calcification or severe atheromas
* Target vessel wall properties where the C-Port anastomosis will be placed are suitable for hand-sewn anastomosis
* Target vessel diameter is ≥ 1.3 mm
* Target vessel has a single wall thickness ≤ 0.75mm
* Hemodynamically stable
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01478061
Study Brief:
Protocol Section:
NCT01478061