Investigation of Renzan Stent for treating leg artery disease in Tuscany

A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)

This study is testing a new type of stent to see if it can safely help people with leg artery disease feel better and improve their blood flow.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Azienda Ospedaliera Universitaria Senese (Academic / other)
• Locations: 1 site (Siena)
• Trial ID: NCT05701293 on ClinicalTrials.gov

What this trial studies

The CURRENT Registry is a prospective, multicenter, observational study aimed at evaluating the safety and efficacy of the Renzan™ Peripheral Stent System in patients with femoropopliteal disease. Approximately 100 patients will be enrolled who meet specific criteria, including those with significant arterial stenosis or occlusion. The study focuses on the use of a modern nitinol stent designed to provide structural support and pharmacological treatment for complex lesions, addressing concerns about the efficacy of existing drug-coated technologies. Participants will be monitored for outcomes related to their treatment over a specified follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Rutherford-Becker clinical classification categories 2 to 5 and significant arterial lesions.

Not a fit: Patients with less severe arterial disease or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from peripheral arterial disease.

How similar studies have performed: While there is ongoing debate regarding the efficacy of drug-eluting technologies, this study represents a novel approach with the Renzan stent, which has not been extensively tested in similar settings.

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)

Where this trial is running

Siena

• University of Siena — Siena, Italy (Recruiting)

Study contacts

• Study coordinator: Gianmarco de Donato, MD

Conditions Peripheral Arterial Disease; peripheral arterial disease; chronic limb threatening ischemia; endovascular treatment