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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT02096757
Eligibility Criteria:
Inclusion Criteria:
* Disabling claudication or CLI as indication for PVI (Rutherford Class II-V)
* Objective evidence of PAD e.g. ABI \< 0.9, TBI \< 0.6 or absent pedal pulses
* Currently not taking high-dose n-3 PUFA, as defined by \>2 g/day
* Able to provide written informed consent AND
* Undergoing a PVI (catheter-based therapy) involving the aorto-iliac segment, superficial femoral artery or popliteal artery.
Exclusion Criteria:
* Age \< 40 or \> 90 years
* Undergoing open surgical revascularization
* Evidence of active infection in limb or foot or osteomyelitis
* Extensive tissue loss (Rutherford Class VI Disease)
* Diagnosed hypercoagulable state
* Non-atherosclerotic/aneurysmal disease as indication for procedure
* Chronic liver disease or myopathy
* End-stage renal disease (CKD 5)
* Poorly controlled diabetes (HbA1C \> 8%)
* Recent other major surgery or illness within 6 weeks
* Use of immunosuppressives or chronic inflammatory disorders
* History of organ transplantation
* Pregnancy or plans to become pregnant
* Condition in which patient life expectancy is less than one year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
90 Years
Study:
NCT02096757
Study Brief:
Protocol Section:
NCT02096757