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 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01066832
Eligibility Criteria:
Inclusion Criteria:
* Patients, male or female, \> 18 years of age;
* Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
* The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
* The target lesion is in a native vessel;
* Up to two lesions per patient;
* Target lesion(s) stenosis is \> 50%.
Exclusion Criteria:
* The patient has had an acute myocardial infarction within the last 48 hours;
* The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to \<12 months);
* Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
* The patient has had previous therapeutic radiation to the target vessel;
* The patient is unable the take dual antiplatelet therapy for at least 6 months;
* Patients with three or more lesions with in-stent restenosis requiring angioplasty.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01066832
Study Brief:
Protocol Section:
NCT01066832