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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT02043795
Eligibility Criteria:
Criteria for Recruitment
At the investigator site, the investigators will recruit patients in accordance to the study protocol, local regulatory requirements, and the ICH-GCP guidelines. When a patient is identified, he/she will be informed about the study. The study will be fully explained to the patient including study objectives, methods, anticipated benefits/risks and discomforts he or she may experience. Summary of this information will be provided in writing using the Informed Consent Form. Patients will be given the opportunity to clarify any issues/questions with the investigator and given adequate time to consider participating in the study or not. Signed and dated informed consent of the patients will be obtained before the commencement of any study related procedures.
Inclusion Criteria:
* Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
* A maximum of 2 target lesions in one or more infrapopliteal vessels
* Minimum of 1mm overlap of stents
* Reference vessel diameter should be 2-4.0 mm
* Symptomatic critical limb ischemia (Rutherford 4, 5, 6)
* The patient must be \> 21 years of age
* Life-expectancy of more than 12 months
* The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
* The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
* The patient must provide written patient informed consent
Exclusion Criteria:
* Patient refusing treatment
* The reference segment diameter is not suitable for available stent design
* Unsuccessfully treated (\>50% residual stenosis) proximal inflow limiting arterial stenosis
* Untreatable lesion located at the distal outflow arteries
* Lesion location requiring kissing stent procedure
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/anti-platelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient takes Phenprocoumon (Marcumar).
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* Subject is receiving immunosuppression therapy, or has known serious immunosuppressive disease (e.g., human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., systemic lupus erythematosus, etc.) The patient should also not receive inhibitors of CYP3A (such as Itraconazole, and Erythromycin), or inducers of CYP3A (such as Rifampin) within 90 days following the procedure.
* Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure to the target vessel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02043795
Study Brief:
Protocol Section:
NCT02043795