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:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT06141694
Eligibility Criteria:
Inclusion Criteria:
1. The subject is age 22-80 years at screening.
2. The subject has been informed of the nature of the study and is willing and able to provide informed consent to participate in the study.
3. The subject has a clinical indication for an elective PVI.
4. The subject is willing and able to comply with all required study procedures.
5. Subject's scheduled procedure is compatible with commercially available peripheral interventional devices that have the following diameter ranges:
1. Guidewires: 0.014-0.018"
2. Catheters (Microcatheters): 2-3 Fr
3. Guide catheter: 4-6 Fr
Exclusion Criteria:
1. Subject is planned to undergo coronary and/or neuro-interventional procedures during study procedure.
2. Subject with vasculature that cannot accommodate the catheter or required accessories according to local routine practice guidelines.
3. Subject with contraindication to endovascular approach to the treatment of peripheral vascular disease, similar or same as contraindications in manual procedures.
4. Target vessel has been previously treated with any type of a bypass conduit.
5. Subject has a contraindication to standard anticoagulation for PVIs.
6. Subject has bleeding or a hypercoagulability disorder.
7. Subject has thrombocytopenia (\<50 x103 per µL).
8. Subject has abnormal, clinically relevant lab results resulting in treatment and/or increased risk to the subject.
9. Subject has an elevated serum creatinine (≥2.5 mg/dL or ≥221 mmol/L).
10. Subject has an active infection requiring antibiotic or anti-fungal systemic treatment.
11. Subject has a known allergy to any material used or any component of the devices used that will be in direct contact with subject's tissue.
12. Subject is pregnant or lactating.
13. Subject with any medical, social, or psychological conditions which, in the opinion of the investigator, would prohibit appropriate consent or impair completion of the study protocol or study procedures.
14. Subject who is incapable, per the investigator's discretion, of following-up with the study visit schedule for any reason.
15. Subject is currently participating in an investigational drug or device study or post market registry, or participated in another investigational drug or device study within one month prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
80 Years
Study:
NCT06141694
Study Brief:
Protocol Section:
NCT06141694