Actively Recruiting
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
208 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
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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provide written informed consent before treatment
- Willing to attend follow-up evaluations as scheduled
- Rutherford-Becker classification category 2 to 5 with resting ankle-brachial index of 0.9 or less
- Lesion in common femoral, superficial femoral, or popliteal artery with more than 50% narrowing or total blockage
- Lesions can be stenotic or occluded with no length limits
- De novo or restenotic/occluded lesions including in-stent restenosis with vessel diameter between 4.0 mm and 8.0 mm
- Multiple Renzan stents allowed with 0.5 to 1 cm overlap
- Patent inflow artery without significant lesions (50% or less narrowing), with successful iliac artery treatment if needed
- Target lesion can be crossed with guide wire and dilated to match stent size
- At least one native outflow artery patent without significant narrowing and not previously treated
You will not qualify if you...
- Rutherford-Becker classification category 6
- Lesions requiring adjunctive debulking devices
- Use of drug-eluting balloons or stents
- Inadequate vessel preparation with more than 20% residual narrowing
- Use of different stent platforms concurrently
- Significant vessel tortuosity or other issues preventing access or stent delivery
- Coronary intervention within 90 days before or planned within 30 days after treatment
- Allergies or intolerance to nitinol
- Contraindications or unresponsiveness to dual antiplatelet or anticoagulation therapy
- Presence of acute thrombus before crossing lesion
- Thrombolysis within 72 hours before the procedure
- Thrombophlebitis or deep venous thrombosis within 30 days
- Dialysis within 30 days
- Stroke within 90 days
- Pregnancy or childbearing potential
- Life expectancy less than 1 year
- Participation in another investigational study without primary endpoint
- Only one patent outflow artery with significant narrowing (50% or more)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Siena
Siena, Italy, 53100
Actively Recruiting
Research Team
G
Gianmarco de Donato, MD
CONTACT
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
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