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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT03720704
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years.
* Signed informed consent form
* Endovascular indication for treatment based on treating physician's best medical judgment.
* Intend for no other stents to be placed in the same peripheral vessel(s) targeted for VBX Stent Graft placement.
* Willingness of the patient to adhere to standard of care follow-up requirements.
Exclusion Criteria:
* Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.
* Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.
* Pregnant or breast-feeding female at time of informed consent signature.
* Life expectancy \< 12 months due to comorbidities.
* Use of the VBX Stent Graft is for the treatment of de novo iliac occlusive disease.
* Use of the VBX Stent Graft is for the treatment of aortic coarctations.
* Use of the VBX Stent Graft in the coronary, pulmonary, carotid, vertebral, isolated infrarenal aortic, or vena cava vessels.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03720704
Study Brief:
Protocol Section:
NCT03720704