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 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT03005418
Eligibility Criteria:
Inclusion Criteria:
1. Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction
2. Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6mm Human Acellular Vessel (HAV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations.
3. Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization
4. Aged 18 to 85 years old, inclusive
5. Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures
6. Patient or relative is able, willing and competent to give informed consent
7. Life expectancy of at least 1 year
Exclusion Criteria:
1. Mangled Extremity Severity Score (MESS) of ≥ 7
2. Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)
3. Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) \> 5 or Injury Severity Score (ISS) \>60)
4. HAV may not be used for coronary artery repair
5. Known pregnant women
6. Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries
7. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the HAV
8. Previous exposure to HAV
9. Known participation in any investigational study within the last 30 days
10. Employees of the sponsor or patients who are employees or relatives of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03005418
Study Brief:
Protocol Section:
NCT03005418