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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT01334866
Eligibility Criteria:
Inclusion Criteria:
* \> or equal to 18 and \< or equal to 80 years of age
* Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)
* Left ventricle ejection fraction \>30%
* Willing and able to provide written informed consent and comply with study requirements
Exclusion Criteria:
* Severe cerebrovascular disease within 90 days of surgery including history of prior stroke.
* Previous cardiac surgery procedures such as CABG revisions, surgical ablations or valve replacements
* Congestive heart failure with a New York Heart Association (NYHA) Class IV
* History of renal insufficiency (i.e. prior serum creatinine of \>2mg/dl) and/or requiring dialysis
* Uncontrolled diabetes (i.e. \>2 serum glucose concentrations of \>350 mg/dl)
* Severe uncontrolled systemic hypertension (i.e. systolic pressure \>160 mmHg)
* Peripheral/systemic active infection excluding the patient from cardiac surgery
* Life expectancy of less than 1 year due to other illness such as cancer or pulmonary, hepatic or renal disease
* Participation in another investigational protocol that may confound the results of this study
* Female of child bearing potential and lactating or intends to become pregnant during the study
* Severe distal disease and small posterior lateral targets
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01334866
Study Brief:
Protocol Section:
NCT01334866