AzTrials
AzTrials

Superficial Femoral Artery DiseasePRIZERNCT04546477

Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease

A study testing Stent implantation in people with Superficial Femoral Artery Disease and Popliteal Artery Disease, run by Terumo Europe N.V. at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease. This trial plans to include 135 patients in (up to) 10 locations around in Europe. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stent implantation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
13 sitesin 5 countries
Study dates
30 Jul 2020to 10 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

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

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.
  • A superficial femoral and/or popliteal artery lesion with > 50% stenosis or total occlusion.
  • Stenotic or occluded lesion(s) within the same vessel (one long or multiple serial lesions treatable with one stent) ≥ 40 mm and ≤ 140 mm in length, with reference vessel diameter (RVD) ≥ 4.0 mm and ≤ 7.0 mm by visual assessment.
Show all 11Show fewer
  • A patent inflow artery free from 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 attainment of residual diameter stenosis ≤30% without death or major vascular complication, either with PTA or stenting.
  • The target lesion(s) can be successfully crossed with a guide wire and dilated up to 1:1 to healthy vessel (as per operator's assesment).
  • At least one patent native outflow artery (anterior or posterior tibial or peroneal) to the foot, 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 only with uncoated devices and before the target lesion.
  • A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator's discretion, who may use the criteria of lesion length, percent stenosis, and/or calcification content. The contra-lateral procedure should not be done until at least 30 days after the index procedure; however, if contralateral treatment is performed prior to treatment of the target lesion it should be performed at least 1 day before the index procedure with uncoated devices only.
  • The subject is eligible for surgical repair, if necessary.

Who cannot join

  • Subject has Rutherford-Becker classification category 6.
  • Treatment of lesions requiring the use of adjunctive debulking devices.
  • The use of drug-coated balloons at any step of the procedure.
  • Required stent placement via a popliteal approach.
  • Required stent placement across or within 0.5 cm of the superficial and profunda femoral artery bifurcation.
  • In-stent restenosis treatment or any other procedure which requires stent-in-stent placement to obtain patency.
Show all 24Show fewer
  • Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
  • Lesion with the length that would require stent overlap.
  • Required stent placement within 1 cm of a previously deployed stent.
  • 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), or contrast agent.
  • 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, where complete resolution of the thrombus was not achieved.
  • 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 or suspected active infection at the time of the procedure.
  • Subject is pregnant or of child bearing potential
  • Subject has life expectancy of less than 1 year.
  • Subject is participating in an investigational study that has not reached primary endpoint at the time of study screening.
  • Treatment of outflow arteries (anterior or posterior tibial or peroneal) following target lesion treatment (unless bailout).
  • In France: Vulnerable patients, patients deprived from liberty and patients with a physical or mental state altered by disease, age or disability which impacts their ability to defend their interests and for which protection measures are taken ("protected majors" as per French law: articles L1121-5, 6, 8 et L1122-1-3, du code de la santé publique)

Trial locations and contacts

13 sites in 5 countries.

13 sites in 5 countries

Belgium4 sites

  • Onze Lieve Vrouw (OLV) Ziekenhuis

    Aalst, 9300

  • Imelda ziekenhuis

    Bonheiden, 2820

  • AZ Sint-Blasius

    Dendermonde, Oost-Vlaanderen, 9200

  • Ziekenhuis Oost Limburg

    Genk, 3600

Other trials in Belgium

France3 sites

  • Clinique Rhône-Durance

    Avignon, 84000

  • Hôpital Paris Saint-Joseph

    Paris, 75014

  • Clinique Saint Jean - Sud de France

    Saint-Jean-de-Védas, 34433

Other trials in France

Germany3 sites

  • Klinikum Hochsauerland Karolinen-Hospital Hüsten

    Arnsberg, 59759

  • CCB MVZ Frankfurt und Main-Taunus GbR

    Frankfurt, 60389

  • Elblandklinikum Radebeul

    Radebeul

Other trials in Germany

Spain2 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Cruces

    Bilbao, 48903

Other trials in Spain

Netherlands1 site

  • Diakonessenhuis

    Utrecht, 3582

Other trials in Netherlands

About this study

Official title: Prospective, Multicenter, Post-market, Single Arm Study to Confirm the Performance of the RenzanTM Peripheral Stent System in Treating Superficial Femoral and/or Popliteal Artery Disease

The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.

This trial plans to include 135 patients in (up to) 10 locations around in Europe.

Read the detailed description

PRIZER Study is a prospective, multicenter, post-market, single arm study with plan to include approximately 135 patients eligible to be treated with RenzanTM Peripheral Stent System stratified in 2 groups: 90 FEM-POP patients (From superficial femoral Artery to the Proximal edge of patella) and 45 Isolated POP patients (From Hunter's canal to the Origin of anterior tibial artery).

The sponsor will work in accordance with standard operating procedures (SOP) and the Monitoring Plan in order to ensure adherence to the CIP and applicable regulations at the investigational sites.

The Monitoring Plan is built according to a risk-based monitoring approach and describes the level of source data verification to be performed by the monitors.

Risk-based monitoring approach uses all available means to supervise the trial (central monitoring, remote monitoring and on-site monitoring), focusing in critical data points and issues ensuring that adequate monitoring (central, remote and on-site) at each site is completed to ensure protection of the rights and safety of the subjects and the quality and integrity of the data collected and submitted.

The sponsor shall provide training and the necessary guidelines to assist each investigational site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality and avoid missing information in the eCRF, edit checks are designed during database development. In addition, Sponsor's CRA and Data Management team will be responsible to review the data and raise queries accordingly into the eCRF. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.

Being tested
Stent implantation
Keywords
Femoropopliteal, Peripheral intervention, Peripheral stent system

What participants receive

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

  • Stent implantationDevice

    Procedure can be conducted via either contralateral or antegrade approach. After a successful target lesion crossing, predilate the lesion using either plain old balloon angioplasty (POBA) or (if necessary) any available specialty balloon. The inflated diameter of the balloon should approximate the diameter of the vessel just distal to the lesion. Proper vessel preparation should achieve diameter of 1:1 to healthy vessel (with ≤20% residual stenosis, as per operator's assessment). Adjunctive debulking devices are prohibited.

    Final stent selection should be confirmed after a proper vessel preparation, considering the reference vessel diameter (RVD) for the optimal 1:1 stent-to-vessel sizing. The implanted dual layer length would encompass the entire lesion with the micromesh, covering it from healthy to healthy tissue. Post-dilatation of the stent for more optimal placement may be done at operator's discretion, using standard angioplasty with uncoated balloon.

Study groups in NCT04546477
Study groupRoleWhat they receive
Single ArmOther135 patients stratified into 2 groups: * FEM-POP patients: SFA-P1 * Isolated POP Patients: P1, P2, P3 only It is expected the majority of enrolled patients to be FEM-POP category. In case sufficient Isolated POP patients are enrolled, a sub-analysis will be performed on this group of patients.
Receives: Device: Stent implantation

What is being measured

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

  1. Primary safety endpoint - Death

    Freedom from death.

    Measured: 30 days

  2. Primary efficacy endpoint - TLR

    Freedom from Target Lesion Revascularization (TLR).

    Measured: 30 days

  3. Primary efficacy endpoint - Amputation

    Freedom from any amputation of the index limb.

    Measured: 30 days

  4. Primary efficacy endpoint

    Primary patency of the artery at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR) (excluding TLR due to thrombosis within 30 days)

    Measured: 12 months

Secondary outcomes (16)

  1. Device Success

    Defined as a successful device deployment according to IFU.

    Measured: Intraoperative

  2. Technical Success

    Defined as achievement of a final target lesion residual diameter stenosis of <30% based on angiography.

    Measured: Intraoperative

  3. Procedural Success

    Defined as technical and device success without procedural complication.

    Measured: Intraoperative

  4. Any death

    Cardiovascular death and Non-cardiovascular death

    Measured: at 1, 6, 12, 24, 36 months

  5. Ankle-brachial Index (ABI) on target limb

    Defined as a ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

    Measured: at baseline, 1, 6, 12, 24 and 36 months

  6. Clinically-driven Target Lesion Revascularization (CD-TLR)

    Defined as 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: at 1, 6, 12, 24 and 36 months

  7. Target Lesion Revascularization (TLR)

    Defined as any repeat percutaneous intervention or bypass surgery performed on the target lesion (including 5mm proximal and distal from the implanted stent).

    Measured: at 1, 6, 12, 24 and 36 months

  8. Target Vessel Revascularization (TVR)

    Defined as any repeat percutaneous intervention or bypass surgery performed on the target vessel.

    Measured: at 1, 6, 12, 24 and 36 months

  9. Patency of the target lesion

    Defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR) (excluding TLR due to thrombosis within 30 days). 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: at 6, 24 and 36 months

  10. Limb Ischemia Improvement

    Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to 1.

    Measured: at 1, 6, 12, 24 and 36 months

  11. Major Adverse Events (MAE)

    Defined as 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: at 1, 6, 12, 24 and 36 months

  12. Index Limb Amputations

    Defined as the surgical removal of tissue anywhere from the toe to hip.

    Measured: at 1, 6, 12, 24 and 36 months

  13. Quality of Life (QoL)

    Quality of Life (QoL) assessed as per EQ-5D questionnaire

    Measured: at baseline, 1, 6, 12, 24 and 36 months

  14. Walking performance

    Walking performance assessed as per Walking Impairment Questionnaire (WIQ)

    Measured: at baseline, 1, 6, 12, 24 and 36 months

  15. Rutherford-Becker Scale

    Category 0 = Asymptomatic, no hemodynamically significant occlusive disease, Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication, Category 4 = Ischemic rest pain, Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above trans metatarsal level, functional foot no longer salvageable.

    Measured: at baseline, 1, 6, 12, 24 and 36 months

  16. Clinical Improvement

    Clinical Improvement compared with baseline as per Rutherford-Becker Clinical Improvement Scale

    Measured: at 1, 6, 12, 24 and 36 months

Timeline

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

  1. First posted14 Sep 2020
  2. Study start30 Jul 2020
  3. Primary completion10 Jun 2024
  4. Study completion10 Jun 2026

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Peripheral Stent placement at the location of the initially stenosed or occluded femoropopliteal lesion after proper (1:1 to the reference vessel diameter) vessel preparation without the use of adjunctive debulking devices. Proper vessel preparation should result in ≤20% residual stenosis (as per operator's assessment).
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546477
Sponsor's protocol ID
T134E5
Acronym
PRIZER
Status last verified
Jul 2026
First submitted
6 Feb 2020
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stent implantation in people with Superficial Femoral Artery Disease and Popliteal Artery Disease, run by Terumo Europe N.V. at 13 sites in 5 countries.

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 24 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: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Belgium, France, Germany, Spain, Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary safety endpoint - Death (time frame: 30 days). The study lists 4 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 NCT04546477.

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 9 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in