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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00289835
Eligibility Criteria:
Inclusion Criteria:
* Written and signed informed consent.
* Patients ≥18 years old.
* Clinical indication for cardiac catheterization and SVG angiography.
* Presence of at least one SVG lesion of 30% to 70% diameter stenosis by visual estimation which is (are) not the culprit lesion (s) responsible for the clinical syndrome of the patient.
Exclusion Criteria:
* Ejection fraction \<20%.
* Renal insufficiency with creatinine \> 250 mg/dl.
* Presence of more than 3 moderate SVG stenosis or significant diffuse SVG disease.
* Unsuccessful angioplasty (residual stenosis \>30% and/or TIMI flow \<3) of any other lesion treated during the same procedure.
* Coronary angioplasty of the target SVG in the past.
* Cardiogenic shock .
* Remaining lesion (s) with a treatment planned within the following year.
* Pregnancy.
* Contraindication to aspirin and/or clopidogrel treatment.
* Allergy to paclitaxel.
* Any disease with a limiting life-expectancy (to less than 2 years).
* Definite presence or high suspicion of thrombus or ulceration in the target lesion.
* Target lesion located in the same SVG than the culprit lesion (if present) and the distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion is \< 4 cm.
* Vein graft diameter \< 2.5 mm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00289835
Study Brief:
Protocol Section:
NCT00289835