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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT03166059
Eligibility Criteria:
Inclusion Criteria:
* Adults \> 18 years
* Diagnosis of limb ischemia requiring CDT
* Patient understands and signs the study specific written informed consent form
Exclusion Criteria:
* Patients who are currently participating in another clinical trial of an investigational drug or device that has not concluded the follow-up period
* Patients who cannot adhere to or complete the investigational protocol for any reason
* Inability to provide informed consent or to comply with study assessments (e.g. due to cognitive impairment or geographic distance)
* Patients with bleeding disorders such as thrombocytopenia (platelet count\<100,000/mm3), hemophilia, von Willebrand's disease or anemia (Hgb \<10g/ dL, Hct \< 30%)
* Patients who need a puncture needle longer than 8 cm due to morbid obesity
* Patients who are cachectic and do not have enough subcutaneous tissue/fat to accommodate the CaveoMed device (the two balloons, with 2 ml of contrast-enriched saline in each ballon)
* Patients who are pregnant or lactating
* Patients with documented INR \> 1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitors, unless the glycoprotein IIb/IIIa platelet inhibitor is given as a bolus prior to the CDT as part of the institution's standard of care
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03166059
Study Brief:
Protocol Section:
NCT03166059