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

Peripheral Arterial Disease Clinical Trial

— CURRENT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701293
• Other study ID #: Current01
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 1, 2026

Study information

• Verified date: July 2023
• Source: Azienda Ospedaliera Universitaria Senese
• Contact: Gianmarco de Donato, MD
• Phone: 00390577585123
• Email: dedonato[@]unisi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In the last years, most of the technical evolution of materials dedicated to the treatment of femoropopliteal disease has been focused on drug-eluting technologies. However, in very complex lesions drug-coated balloons seems to be less efficient, leading to a high rate of bailout stenting with bare metal stents. Drug-eluting stents have raised expectation, providing structural scaffolding of the artery and active pharmacological treatment of the target lesion. Available evidence from the literature does not always seem to support this hypothesis. Still, a lot of rumours have been generated on the potential local and systemic toxicity of paclitaxel. As a consequence, in complex lesion rather than Drug Coated Balloon and Drug Eluting Stent it seems that there is need of a modern generation of nitinol stents with high Radial Resistive Force, low chronic outward forces and high fracture resistance. The device under investigation is the Renzan™ Peripheral Stent System from Terumo MicroVention Inc. (35 Enterprise, Aliso Viejo, California 92656, USA) . The System consists of a self-expanding nitinol stent pre-mounted on the distal portion of a rapid exchange (RX) delivery catheter. The stent is made of a nickel-titanium alloy with radiopaque markers on each end of the stent. The nitinol stent is constructed from 2 layers of tubular braided nitinol wire mesh. The outer layer consists of nitinol wire braided into a closed cell structure with flared ends. The inner layer consists of nitinol wire braided into a closed cell structure with micro sized pores. The delivery catheter has a rapid exchange port designed to allow coaxial passage of a 0.46mm (0.018") or smaller guide wire in diameter. The stent is capable of being recaptured when a minimum of 20mm of stent length remains inside the catheter.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Endovascular implantation of Renzan Stent
Endovascular treatment of LEAD patients with Renzan Stent

Locations

Country	Name	City	State
Italy	University of Siena	Siena

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Senese	University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH; GVG Writing Group. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019 Jun;69(6S):3S-125S.e40. doi: 10.1016/j.jvs.2019.02.016. Epub 2019 May 28. Erratum In: J Vasc Surg. 2019 Aug;70(2):662. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety endpoint [composite]	Death + target lesion revascularization (TLR) + Major Amputation (above the ankle)	30 days after procedure
Primary	Primary Efficacy endpoint	Primary patency of the artery at 12 months, defined as no evidence of occlusion within the originally treated lesion based on Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR)	12 months
Secondary	Device Success	Successful device deployment according to Instruction For Use.	Intraoperative
Secondary	Technical Success	Achievement of a final target lesion residual diameter stenosis of <30% based on angiography.	Intraoperative
Secondary	Procedural Success	Technical and device success without procedural complication.	Intraoperative
Secondary	Any death	Cardiovascular death and non-cardiovascular death	1, 6, 12 24 and 36 months
Secondary	Clinically-driven Target Lesion Revascularization (CD-TLR)	Any TLR associated with deterioration of patient's Rutherford category and/or increase in size of pre-existing ischemic wounds and/or occurrence of new wounds.	1, 6, 12 24 and 36 months
Secondary	Patency of Target lesion	Defined as no evidence of restenosis or occlusion within the originally treated lesion based on a Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity ratio (PSVR) of = 2.4 when compared to the proximal normal segment, respectively.	1, 6, 12 24 and 36 months
Secondary	Limb Ischemia Improvement	Improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to 1.; -Rutherford-Becker Classification: 0 Asymptomatic; Mild claudication; Moderate claudication; Severe claudication; Ischemic rest pain; Minor tissue loss; Major tissue loss	1, 6, 12 24 and 36 months
Secondary	MAE (Major Adverse Event)	a composite rate of: cardiovascular death; procedure-related arterial rupture; acute limb ischemia; stent thrombosis; clinically apparent distal embolization; target limb amputation; procedure-related bleeding event requiring transfusion	1, 6, 12 24 and 36 months
Secondary	Index Limb Amputation	Amputation above the ankle.	1, 6, 12 24 and 36 months
Secondary	Stent deployment performance evaluation	Operators feedback on: Pushability/Trackability, Deployment, Visibility and Precise Placement; -High, Moderate and Low	Intraoperative