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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT02797158
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years
* Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main
* Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision.
Exclusion Criteria:
* Recent acute coronary syndrome (within 30 days before randomization),
* Unprotected left main disease
* Critical stenosis (\>90%) of Left Anterior Descending artery (LAD),
* Significant angina (CCS class more than 2)
* Active bleeding,
* Contraindication for tomographic technetium-99 assessment or dipyridamole injection
* Previous enrollment in a other study
* Impossibly to obtain consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02797158
Study Brief:
Protocol Section:
NCT02797158