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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT02734095
Eligibility Criteria:
Inclusion Criteria:
* Stenotic (\>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
* Successful lesion passage passed with conventional mechanical guidewires;
* Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
* Life-expectancy of more than 12 months;
* Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
* Te patient must provide written patient informed consent that is approved by the ethics committee.
Exclusion Criteria:
* Patient refusing treatment;
* The reference segment diameter is not suitable fo available balloon and/or stent design;
* Unsuccessfully treated (\>30% residual stenosis) proximal inflow limiting arterial stenosis;
* Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
* The patent has a history of prior life-threatening contrast media reaction;
* The patient is currently enrolled in another investigational device or drug trial;
* The patient is currently breast-feeding, pregnant or intends to become pregnant;
* The patient is mentally ill or retarded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT02734095
Study Brief:
Protocol Section:
NCT02734095