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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06872905
Eligibility Criteria:
Inclusion Criteria:
1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).
2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.
3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.
4. Age ≥18 years at the time of CERAB procedure.
5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)/Ethics Committee (EC) -
Exclusion Criteria:
1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.
2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).
3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06872905
Study Brief:
Protocol Section:
NCT06872905