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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01495533
Eligibility Criteria:
Inclusion Criteria:
* \>18 years of age
* clinical evidence of stable or unstable angina or a positive functional study
* patients with ≤ 2 primary in-stent restenosis (ISR) lesions (≥ 70% diameter stenosis) within previously placed bare metal stents (BMS)
Exclusion Criteria:
* acute myocardial infarction within the past 72 hours
* chronic renal insufficiency with serum creatinine levels \>2.0 mg per deciliter%
* known hypersensitivity or contraindications to aspirin, heparin, clopidogrel, ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication
* concomitant medical illness associated with a life-expectancy of less than two years
* stented segment length ≥30 mm, vessel diameter \<2.5 mm, diameter stenosis \<70%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01495533
Study Brief:
Protocol Section:
NCT01495533