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 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT02693158
Eligibility Criteria:
Inclusion Criteria:
1. Subject is ≥ 18 years old;
2. Subject has symptomatic heart disease due to coronary artery lesions of length \< 28 mm and a reference vessel diameter 2.5 - 4.0 mm.
3. Subject is intended to be treated with PCI and implantation of SLENDER IDS as part of his/her standard treatment
4. Subject or subject's legal representative understands the study requirements and the treatment procedures and provides written informed consent before any study specific tests or procedures are performed.
Exclusion Criteria:
1. Subject is unable to receive anti-platelet and/or anti-coagulant therapy;
2. Subject is allergic to sirolimus, PEA III Ac Bz, cobalt, chromium, nickel or tungsten;
3. The subject is judged to have lesions preventing complete inflation of an angioplasty balloon or proper placement of a coronary stent, including chronic total occlusions.
4. Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential, based on the standard of care for the cath lab);
5. Subject is participating in another investigational drug or device clinical trial that the investigator feels would interfere with the subject's participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02693158
Study Brief:
Protocol Section:
NCT02693158