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 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT00914420
Eligibility Criteria:
Inclusion Criteria:
Clinical
* \>18 years of age,
* symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but \<48 h
* Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board
Angiographic
* reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate)
* discrete target lesion (maximum length of 28 mm by visual estimation)
* target lesion is in a native coronary artery
* presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter.
Exclusion Criteria:
Clinical
* previously documented left ventricular ejection fraction of less than 30%
* estimated life expectancy of less than 12 months
* a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
* participation in another study
* inability to give informed consent owing to prolonged cardiopulmonary resuscitation
* and dominant Renal impairment (serum creatinine \> 2.0 mg/dl) Angiographic
* non-culprit lesion located in the proximal LAD or in a proximal and dominant Circumflex artery
* previous PCI of the target vessels restenosis or stent thrombosis as culprit lesion
* unprotected left main coronary artery disease
* non-culprit lesion located in a vein graft
* severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00914420
Study Brief:
Protocol Section:
NCT00914420