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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT02468960
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years.
* Able and willing to give informed consent.
* Willing to comply with specified follow-up evaluations.
* Clinical manifestation of coronary artery disease: stable angina, unstable angina or non-ST-elevation myocardial infarction.
* De novo lesion.
* Angiographic diameter stenosis \> 70 % and/or fractional flow reserve \<0.80.
* Vessel diameter between 2.5 and 4.0 mm.
* One- or two vessel disease (defined as diameter stenosis \> 70 % in vessels with a diameter \> 2.5 mm).
* Up to two lesions in one or two vessels can be treated
Exclusion Criteria:
* Patient characteristics
* Pregnant or nursing patient or planned pregnancy in the period up to 1 year following the index procedure.
* Patient with contraindication for 12 months of dual antiplatelet therapy.
* ST-elevation myocardial infarction.
* Any contraindication to the implantation of BVS. Lesion characteristics
* Visible thrombus in coronary angiography
* Chronic total occlusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02468960
Study Brief:
Protocol Section:
NCT02468960