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Peripheral Arterial DiseaseCURRENTNCT05701293

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

An observational study of Peripheral Arterial Disease, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Endovascular implantation of Renzan Stent
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteItaly
Study dates
1 Dec 2022to 1 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gianmarco de Donato, MD contact

00390577585123

dedonato@unisi.it

Italy1 site, 1 recruiting

  • University of Siena

    Siena, 53100

    Edoardo Pasqui, MD, 00390577585127

    Raffaele Pulli, MD

    Recruiting

Other trials in Italy

About this study

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 the detailed 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.

Being tested
Endovascular implantation of Renzan Stent
Keywords
peripheral arterial disease, chronic limb threatening ischemia, endovascular treatment
Medical subject headings
Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular implantation of Renzan StentProcedure or surgery

    Endovascular treatment of LEAD patients with Renzan Stent

Study groups in NCT05701293
Study groupRoleWhat they receive
LEAD patients undergoing endovascular treatment with implantation of Renzan stentNot described
Receives: Procedure: Endovascular implantation of Renzan Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Safety endpoint [composite]

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

    Measured: 30 days after procedure

  2. 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)

    Measured: 12 months

Secondary outcomes (10)

  1. Device Success

    Successful device deployment according to Instruction For Use.

    Measured: Intraoperative

  2. Technical Success

    Achievement of a final target lesion residual diameter stenosis of <30% based on angiography.

    Measured: Intraoperative

  3. Procedural Success

    Technical and device success without procedural complication.

    Measured: Intraoperative

  4. Any death

    Cardiovascular death and non-cardiovascular death

    Measured: 1, 6, 12 24 and 36 months

  5. 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.

    Measured: 1, 6, 12 24 and 36 months

  6. 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.

    Measured: 1, 6, 12 24 and 36 months

  7. 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

    Measured: 1, 6, 12 24 and 36 months

  8. 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

    Measured: 1, 6, 12 24 and 36 months

  9. Index Limb Amputation

    Amputation above the ankle.

    Measured: 1, 6, 12 24 and 36 months

  10. Stent deployment performance evaluation

    Operators feedback on: Pushability/Trackability, Deployment, Visibility and Precise Placement

    -High, Moderate and Low

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start1 Dec 2022
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701293
Sponsor's protocol ID
Current01
Acronym
CURRENT
Status last verified
Jul 2023
First submitted
18 Jan 2023
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31159978

Questions about this trial

What is this clinical trial studying?

An observational study of Peripheral Arterial Disease, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gianmarco de Donato, MD (00390577585123, dedonato@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety endpoint [composite] (time frame: 30 days after procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701293, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

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