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

Trial details

Who runs it

Azienda Ospedaliera Universitaria Senese

Trial code

NCT05701293

Record updated

20 July 2023

Original description

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.Read full original descriptionShow less

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.

Inclusion: Age ≥18 years; Subject must provide written informed consent prior to the treatment of the target lesion; Subject must be willing to comply with the specified follow-up evaluation schedule; Subject with Rutherford-Becker clinical classification category 2 to 5, with a resting ankle-brachial index (ABI) ≤ 0.9; Common femoral, superficial femoral and/or popliteal artery lesion with > 50% stenosis or total occlusion; 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 (RVD) ≥ 4.0 mm and ≤ 8.0 mm by visual assessment and no length limits; Multiple RENZAN stents could be deployed with a mandatory overlap of 0.5-1 cm; 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; 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); 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: Use of drug-eluting balloon or stent; Concomitant use of different stent platforms; Subject with coronary intervention performed less than 90 days prior to or planned within 30 days after the treatment of the target lesion; Any contraindication or known unresponsiveness to dual antiplatelet therapy (DAPT) or anticoagulation therapy; Presence of acute thrombus prior to crossing the lesion; Thrombolysis of the target vessel within 72 hours prior to the index procedure; Thrombophlebitis or deep venous thrombus, within the previous 30 days; Subject receiving dialysis within the previous 30 days; Stroke within the previous 90 days; Known allergies or intolerance to nitinol (nickel titanium); Subject has Rutherford-Becker classification category 6; Treatment of lesions requiring the use of adjunctive debulking devices; 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); Any significant vessel tortuosity or other parameters prohibiting access to the lesion and/or preventing the stent delivery; Subject is pregnant or of childbearing potential; Subject has a life expectancy of less than 1 year; Subject is participating in an investigational study that has not reached the primary endpoint at the time of study screening; Only one patent outflow artery, with significant stenosis (≥50%) (as confirmed by angiography).

ClinicalTrials.gov NCT05701293