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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01262703
Eligibility Criteria:
Inclusion Criteria:
* Evidence of myocardial ischemia or a positive functional study.
* Normal CK-MB.
* Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
* Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 100% with a TIMI flow of ≥ 2.
* Staged procedures are allowed in non-target vessels \>24 hours before or \> 30 days after REVA stent implantation
Exclusion Criteria:
* A myocardial infarction (CK-MB or Troponin \> 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
* Unprotected left main coronary disease with \>50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 to 1)
* Target lesion involves a bifurcation (a lesion with a side branch \>2.0 mm in diameter containing a \>50% stenosis)
* Target lesion is located within a segment supplied by distal graft
* Target lesion has possible or definite thrombus
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01262703
Study Brief:
Protocol Section:
NCT01262703