NCT05701293 A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)
| NCT ID | NCT05701293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Universitaria Senese |
| Condition | Peripheral Arterial Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2023-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-12-01 with a primary completion date of 2023-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
CURRENT Registry is a physician-initiated prospective, multicenter, post-market, single-arm study with a plan to include approximately 100 patients eligible to be treated with RenzanTM Peripheral Stent System.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05701293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05701293 currently recruiting?
Yes, NCT05701293 is actively recruiting participants. Contact the research team at dedonato@unisi.it for enrollment information.
Where is the NCT05701293 trial being conducted?
This trial is being conducted at Siena, Italy.
Who is sponsoring the NCT05701293 clinical trial?
NCT05701293 is sponsored by Azienda Ospedaliera Universitaria Senese. The trial plans to enroll 100 participants.