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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT00151658
Eligibility Criteria:
Inclusion Criteria:
Stable, or unstable angina and/or objective signs of myocardial ischaemia Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.
Complex lesions to be included should have at least one of the following characteristics:
* Ostial in location (\< 5 mm from ostium)
* Total occlusions with a length ≥ 15 mm
* Bifurcational (side branch \> 1.75 mm in diameter)
* Angulated (\> 45° within lesion)
Exclusion Criteria:
Patients:
* Other severe disease with an expected survival \< 1 year
* Other significant cardiac disease
* Known allergy against paclitaxel, clopidogrel or stainless steel.
* Myocardial infarction within 3 days of the index procedure
* Linguistic difficulties needing an interpreter
* Renal insufficiency (p-creatinine \> 200 micromol/l)
* Gastrointestinal bleeding within 1 month
* Childbearing potential or pregnancy
* Participation in another study
Lesions:
* Unprotected left main disease
* Restenosis
* Lesions containing visible thrombus
* Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
* Diffuse coronary disease distal to the treated lesion
* Heavily calcification
* Lesion located in saphenous vein graft
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00151658
Study Brief:
Protocol Section:
NCT00151658