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 @ 12:57 AM
Ignite Modification Date:
2025-12-25 @ 12:57 AM
NCT ID:
NCT05701293
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years.
2. Subject must provide written informed consent prior to the treatment of the target lesion.
3. Subject must be willing to comply with the specified follow-up evaluation schedule.
4. Subject with Rutherford-Becker clinical classification category 2 to 5, with a resting ankle-brachial index (ABI) ≤ 0.9.
5. Common femoral, superficial femoral and/or popliteal artery lesion with \> 50% stenosis or total occlusion.
6. Stenotic or occluded lesion(s) within the same vessel with no length limits.
7. De novo or restenotic/occluded lesion(s) including in-stent restenosis, with reference vessel diameter (RVD) ≥ 4.0 mm and ≤ 8.0 mm by visual assessment and no length limits.
8. Multiple RENZAN stents could be deployed with a mandatory overlap of 0.5-1 cm.
9. A patent inflow artery free from the significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); Successful ipsilateral iliac artery treatment is defined as the attainment of residual diameter stenosis ≤30%, either with PTA or stenting.
10. The target lesion(s) can be successfully crossed with a guide wire and dilated up to 1:1 to the proposed stent to be implanted (as per the operator's assessment).
11. At least one patent native outflow artery (anterior or posterior tibial or peroneal), free from significant (≥50%) stenosis (as confirmed by angiography), that has not previously been revascularized. The remaining outflow arteries requiring treatment during the same procedure may be treated
Exclusion Criteria:
1. Subject has Rutherford-Becker classification category 6.
2. Treatment of lesions requiring the use of adjunctive debulking devices.
3. Use of drug-eluting balloon or stent
4. Inadequate vessel preparation not achieving a diameter of 1:1 to the stent to be implanted (with ≤20% residual stenosis, as per operator's assessment).
5. Concomitant use of different stent platforms
6. Any significant vessel tortuosity or other parameters prohibiting access to the lesion and/or preventing the stent delivery.
7. Subject with coronary intervention performed less than 90 days prior to or planned within 30 days after the treatment of the target lesion.
8. Known allergies or intolerance to nitinol (nickel titanium).
9. Any contraindication or known unresponsiveness to dual antiplatelet therapy (DAPT) or anticoagulation therapy.
10. Presence of acute thrombus prior to crossing the lesion.
11. Thrombolysis of the target vessel within 72 hours prior to the index procedure
12. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
13. Subject receiving dialysis within the previous 30 days.
14. Stroke within the previous 90 days.
15. Subject is pregnant or of childbearing potential
16. Subject has a life expectancy of less than 1 year.
17. Subject is participating in an investigational study that has not reached the primary endpoint at the time of study screening.
18. Only one patent outflow artery, with significant stenosis (≥50%) (as confirmed by angiography)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05701293
Study Brief:
Protocol Section:
NCT05701293