Global vascular guidelines on the management of chronic limb-threatening ischemia.
Michael S Conte, Andrew W Bradbury, Philippe Kolh...
https://pubmed.ncbi.nlm.nih.gov/31159978Actively Recruiting
Age: 18Years +
All Genders
ID05701293
A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)
Led by Azienda Ospedaliera Universitaria Senese · Updated on 2023-07-20
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
A
Azienda Ospedaliera Universitaria Senese
Lead Sponsor
U
University of Florence
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effectiveness of the Renzan14 Peripheral Stent System in treating patients with femoro-popliteal disease, a type of peripheral arterial disease affecting the leg arteries. This prospective, multicenter, single-arm study plans to include about 100 patients eligible for treatment with this stent. The study focuses on evaluating a modern nitinol stent designed for complex lesions where drug-coated balloons and drug-eluting stents may be less effective or raise concerns about toxicity. The Renzan stent is a self-expanding nitinol device pre-mounted on a catheter designed for precise placement in the affected arteries. It consists of two layers of braided nitinol wire mesh with radiopaque markers to assist in positioning during the procedure. The stent can be partly recaptured during placement if needed. This study observes patients undergoing endovascular implantation of the Renzan stent without comparison groups, focusing on the device's performance and safety after treatment. Participants will be followed for assessments of safety and effectiveness, including measurements at 30 days and up to 12 months after the procedure. Key evaluations include device and procedural success during implantation, rates of death, need for further treatment of the treated artery, artery openness, limb ischemia improvement, major adverse events, and limb amputation at multiple time points up to 36 months. Patients will be monitored closely with follow-up visits to track these outcomes and the long-term performance of the stent.
CONDITIONS
Brief Title
A ProspeCtive mUlticenteR Investigation on RENzar Stent Safety and Efficacy in the Treatment of Patients With Femoro-popliteal Disease in Tuscany (CURRENT Registry)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 6518 years
- Willingness to provide written informed consent
- Willingness to comply with follow-up evaluations
- Rutherford-Becker clinical classification category 2 to 5 with resting ankle-brachial index (ABI) 640.9
- Lesion with more than 50% stenosis or total occlusion in common femoral, superficial femoral, and/or popliteal artery
- Stenotic or occluded lesion(s) within the same vessel with no length limits
- De novo or restenotic/occluded lesion(s) including in-stent restenosis with reference vessel diameter 4.0 to 8.0 mm
- Multiple RENZAN stents may be deployed with mandatory overlap of 0.5-1 cm
- Patent inflow artery free from significant lesion (6550% stenosis) confirmed by angiography
- Target lesion can be crossed with guide wire and dilated up to 1:1 to stent
- At least one patent native outflow artery free from significant stenosis, not previously treated
You will not qualify if you...
- Rutherford-Becker classification category 6
- Requirement for adjunctive debulking devices
- Use of drug-eluting balloon or stent
- Inadequate vessel preparation with more than 20% residual stenosis
- Use of different stent platforms concurrently
- Significant vessel tortuosity or other factors preventing stent delivery
- Coronary intervention less than 90 days before or planned within 30 days after treatment
- Known allergy or intolerance to nitinol (nickel titanium)
- Contraindication or unresponsiveness to dual antiplatelet or anticoagulation therapy
- Presence of acute thrombus before crossing lesion
- Thrombolysis within 72 hours before procedure
- Thrombophlebitis or deep venous thrombus within previous 30 days
- Dialysis within previous 30 days
- Stroke within previous 90 days
- Pregnancy or childbearing potential
- Life expectancy less than 1 year
- Participation in another investigational study not reaching primary endpoint
- Only one patent outflow artery with significant stenosis (6550%) confirmed by angiography
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants undergo endovascular implantation of the Renzan Stent as treatment for femoro-popliteal disease.
1 visit (in-person) for the implantation procedure
Monitoring
Duration - Up to 36 months
Participants are monitored for safety and efficacy of the stent with follow-up visits to assess outcomes and adverse events.
Visits at 1, 6, 12, 24, and 36 months post-procedure
Trial Site Locations
Total: 1 location
1
University of Siena
Siena, Italy, 53100
Actively Recruiting
Loading map...
Research Team
G
Gianmarco de Donato, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here