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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Endovascular treatment of LEAD patients with Renzan Stent
University of Siena
Siena, Italy
RECRUITINGPrimary Safety endpoint [composite]
Death + target lesion revascularization (TLR) + Major Amputation (above the ankle)
Time frame: 30 days after procedure
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)
Time frame: 12 months
Device Success
Successful device deployment according to Instruction For Use.
Time frame: Intraoperative
Technical Success
Achievement of a final target lesion residual diameter stenosis of \<30% based on angiography.
Time frame: Intraoperative
Procedural Success
Technical and device success without procedural complication.
Time frame: Intraoperative
Any death
Cardiovascular death and non-cardiovascular death
Time frame: 1, 6, 12 24 and 36 months
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.
Time frame: 1, 6, 12 24 and 36 months
Patency of Target lesion
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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.
Time frame: 1, 6, 12 24 and 36 months
Limb Ischemia Improvement
Improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to 1. -Rutherford-Becker Classification: 0 Asymptomatic 1. Mild claudication 2. Moderate claudication 3. Severe claudication 4. Ischemic rest pain 5. Minor tissue loss 6. Major tissue loss
Time frame: 1, 6, 12 24 and 36 months
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
Time frame: 1, 6, 12 24 and 36 months
Index Limb Amputation
Amputation above the ankle.
Time frame: 1, 6, 12 24 and 36 months
Stent deployment performance evaluation
Operators feedback on: Pushability/Trackability, Deployment, Visibility and Precise Placement -High, Moderate and Low
Time frame: Intraoperative