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 @ 11:45 AM
Ignite Modification Date:
2025-12-24 @ 11:45 AM
NCT ID:
NCT01158261
Eligibility Criteria:
Inclusion Criteria:
* Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
* EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
* Subjects must be willing to and capable of participating in the study, and provide written informed consent
Exclusion Criteria:
* Subjects with known intolerance to blood products
* Subjects unwilling to receive blood products
* Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
* Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01158261
Study Brief:
Protocol Section:
NCT01158261