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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT01065532
Eligibility Criteria:
Inclusion Criteria:
1. Patient older than 18 years
2. written informed consent available
3. patient eligible for percutaneous coronary intervention
4. patients with a single or multiple re-stenotic lesion(s) in a previously stented area of a coronary artery (irrelevant whether BMS or DES)
5. Target reference vessel diameter measured by QCA: 2-4 mm
6. Target lesion length measured by QCA \< 24 mm
7. Target lesion stenosis measured by QCA: \> 70%- \< 100%
8. Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
Exclusion Criteria:
1. Left ventricular ejection fraction of \< 30%
2. Impaired renal function (serum creatinine \> 2.0 mg/dl)
3. Target lesion located in bifurcation
4. Previous and/or planned brachytherapy of target vessel
5. Lesion of the left main trunk \> 50%, unprotected
6. Known allergies to antiplatelet, anticoagulation therapy, contrast media, paclitaxel or everolimus
7. Pregnant and/or breast-feeding females or females who intend to become pregnant (pregnancy test required)
8. Patients with a life expectancy of less than one year
9. Patients who intend to have a major surgical intervention within 6 months of enrolment in the study.
10. Patient currently enrolled in other investigational device or drug trial
11. Patient not able or willing to adhere to follow-up visits
12. Patients who previously participated in this study. -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01065532
Study Brief:
Protocol Section:
NCT01065532