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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT04600934
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 years
* Indicated for planned procedure requiring large bore (\>12 French sheath) access
* Mental capacity to provide informed consent
* Iliac access vessel demonstrates \>50% circumferential calcium
* Iliac access vessel demonstrates maximum inner lumen diameter less than IFU for device required
* Iliac access vessel demonstrates maximum outer wall diameter greater than or equal to IFU for device required
* Preoperative CT angiogram, \</= 5mm slices
* Preoperative ABI/TP
* Unsuccessful delivery of large bore sheath without adjunctive intervention
o Definition of unsuccessful = operator assessment of the following
* Visible distortion of iliac artery calcification under fluoroscopy without forward progress of device
* Adverse forward pressure application by operator
* Failure of device to track with external pressure applied to abdomen
* Patient intolerance of advancement (pain response) in awake patient
Exclusion Criteria:
* Contraindicated for antiplatelet therapy (aspirin or plavix)
* Planned iliofemoral surgical reconstruction in next 30 days
* Prior common or external iliac artery stent placement
* Prior aorto-iliac, aorto-femoral, or iliofemoral bypass present
* Iliac access vessel demonstrates maximum outer wall diameter less than IFU for device required
* Inability to obtain preoperative CTA (contrast allergy, CKD, etc)
* Inability to traverse iliac segment with wire
* Emergent procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04600934
Study Brief:
Protocol Section:
NCT04600934