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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT00892957
Eligibility Criteria:
Inclusion Criteria:
Preoperative inclusion criteria:
* Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:
* axillo-femoral
* axillo-bifemoral
* aorto-bifemoral
* ilio-femoral
* femoro-femoral
* ilio-popliteal
* femoro-popliteal (including below knee)
* femoro-tibial vessel bypass
* arterio-venous shunting for dialysis access in the upper or lower extremity
* Signed informed consent
* Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
* Subject is willing and able to comply with the requirements of the protocol.
Intraoperative inclusion criterion:
* Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)
Exclusion Criteria:
Preoperative exclusion criteria:
* Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
* Congenital coagulation disorders
* Prior kidney transplantation
* Heparin-induced thrombocytopenia
* Known hypersensitivity to heparin
* Known hypersensitivity to aprotinin or other components of the product
* Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)
* Prior radiation therapy to the operating field
* Severe local inflammation at the operating field
* Subject is pregnant or lactating at the time of enrollment
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
* Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.
Intraoperative Exclusion Criteria:
* Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
* Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (eg, abandonment of ePTFE graft placement)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00892957
Study Brief:
Protocol Section:
NCT00892957