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 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT01316159
Eligibility Criteria:
Inclusion Criteria:
* Age at least 18 years old
* Presentation with an ACS (unstable angina pectoris, non-ST elevation MI, or ST-elevation MI)
* Coronary artery disease with at least one coronary segment requiring percutaneous stent deployment using usual clinical indications
* At least 1 vessel suitable for IVUS not planned for PCI.
* Have the ability to understand the requirements of the study, provide written informed consent
Exclusion Criteria:
* Heart failure, defined as NYHA Class III or IV
* Unstable clinical status (ongoing anginal pain or hemodynamic or electrical instability)
* Left main disease or three vessel disease
* In the opinion of the investigator, significant coronary calcification precluding protocol evaluations
* Investigator determination of renal failure of sufficient severity such that additional contrast material is contraindicated
* Clinically significant valvular heart disease
* Investigator opinion of life expectancy \< 12 months
* Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Studies requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational studies)
* Women who are pregnant, seeking to become pregnant or suspect they are pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01316159
Study Brief:
Protocol Section:
NCT01316159