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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01977534
Eligibility Criteria:
Inclusion Criteria:
The inclusion criteria must follow the most recent IFU which may include but are not limited to the following:
* Patient must be at least 18 years of age at the time of signing the Informed Consent Form
* Patient is to be treated for de novo lesions located in previously untreated vessels.
* Patient must agree to undergo all required follow-up visits and data collection.
Exclusion Criteria:
The exclusion criteria must follow the most recent IFU which may include but are not limited to the following:
* Inability to obtain a signed informed consent from potential patient.
* Patient belongs to a vulnerable population (per investigator's judgment, this also includes people with a direct link (hierarchical or financial benefit) to the registry Doctor or the registry Sponsor).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01977534
Study Brief:
Protocol Section:
NCT01977534