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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT02539303
Eligibility Criteria:
Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).
Exclusion:
* Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer.
* Patients with chronic kidney disease stage V (unless on dialysis).
* Patients with liver cirrhosis.
* Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months.
* Patients with history of stroke in the last 3 months.
* Patients with unstable angina or history of myocardial infarction in the last 3 months.
* Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock.
* Women who are pregnant or nursing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT02539303
Study Brief:
Protocol Section:
NCT02539303