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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT02255851
Eligibility Criteria:
Inclusion Criteria:
1. Approved indications for commercially available CE-Marked TAVR devices.
2. Compatible left common carotid artery (6.5 - 10 mm) and brachiocephalic artery (9 - 15 mm) diameters without significant stenosis (\> 70%).
3. The subject or the subject's legal representative has been informed of the nature of the registry, agrees to its provisions and has provided written informed consent as approved by the Ethics Committee of the respective site.
Exclusion Criteria:
1. Vasculature in the right extremity precluding 6Fr sheath radial/brachial access
2. Inadequate circulation to the right extremity as evidenced by signs of artery occlusion or absence of radial or brachial pulse
3. Hemodialysis shunt, graft, or arterio-venous fistula involving the upper extremity vasculature
4. Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated, or who will refuse transfusion
5. Excessive tortuosity in the right radial/brachial/subclavian artery preventing Sentinel device access and insertion
6. Patient whose brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium
7. Currently participating in an investigational drug or investigational (non CE-mark) device study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02255851
Study Brief:
Protocol Section:
NCT02255851