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

NCT05701293 | Recruiting DMC

• 1 other identifier: Current01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease; chronic limb threatening ischemia; endovascular treatment

Outcome Measures

Primary Outcomes (2)

• Primary Safety endpoint [composite]

  Death + target lesion revascularization (TLR) + Major Amputation (above the ankle)

  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)

  12 months

Secondary Outcomes (10)

• Device Success

  Intraoperative

• Technical Success

  Intraoperative

• Procedural Success

  Intraoperative

• Any death

  1, 6, 12 24 and 36 months

• Clinically-driven Target Lesion Revascularization (CD-TLR)

  1, 6, 12 24 and 36 months

Study Arms (1)

LEAD patients undergoing endovascular treatment with implantation of Renzan stent

Procedure: Endovascular implantation of Renzan Stent

Interventions

Endovascular implantation of Renzan Stent PROCEDURE

Endovascular treatment of LEAD patients with Renzan Stent

LEAD patients undergoing endovascular treatment with implantation of Renzan stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of Lower Extremity Artery disease needing for endovascular treatment

You may qualify if:

• 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

You may not qualify if:

• Subject has Rutherford-Becker classification category 6.
• Treatment of lesions requiring the use of adjunctive debulking devices.
• Use of drug-eluting balloon or stent
• 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).
• Concomitant use of different stent platforms
• Any significant vessel tortuosity or other parameters prohibiting access to the lesion and/or preventing the stent delivery.
• Subject with coronary intervention performed less than 90 days prior to or planned within 30 days after the treatment of the target lesion.
• Known allergies or intolerance to nitinol (nickel titanium).
• 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.
• Subject is pregnant or of childbearing potential

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Senese: lead
• University of Florence: collaborator

Study Sites (1)

University of Siena

Siena, 53100, Italy

RECRUITING

Related 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.

  PMID: 31159978 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Gianmarco de Donato, MD

CONTACT

00390577585123; dedonato@unisi.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: January 27, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IT (1)