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ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty

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ClinicalTrials.gov Identifier: NCT03751527
Recruitment Status : Recruiting
First Posted : November 23, 2018
Last Update Posted : August 31, 2021
Sponsor:
Information provided by (Responsible Party):
Zhejiang Zylox Medical Device Co., Ltd.

Study Description
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Brief Summary:
A prospective, multi-center, single-arm registry to evaluate the safety and efficacy of bare metal stent-assisted percutaneous transluminal angioplasty (PTA) in the treatment of superficial femoral and/or proximal popliteal artery (P1) lesions in patients with symptomatic peripheral artery disease

Condition or disease Intervention/treatment Phase
Atherosclerosis of Femoral Artery Device: ZENFLEX peripheral stent system Not Applicable

Detailed Description:

The purpose of this registry is to collect acute and follow-up (up to 12 months) safety and efficacy data on the ZENFlex™ Peripheral Stent System in the stent-assisted angioplasty treatment of patients with de novo or restenotic lesion(s) of the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA, P1 segment) when used according to IFU. Up to 100 subjects will be enrolled in this study at up to 5 sites in Germany.

This study is a prospective, single-arm observational registry and does not include an active control arm. Therefore, no formal sample size calculation has been performed. All subjects will be evaluated at pre-discharge and during clinical follow-up visits 6 (182 ± 30 days) and 12 (365 ± 30 days) months post-procedure.

Primary endpoints are patency rate after one year and composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arms and Interventions
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Arm Intervention/treatment
Experimental: ZENFLEX stent Group
subjects applying ZENFLEX peripheral stent system
 Device: ZENFLEX peripheral stent system
The ZENFLEX Peripheral Stent System is designed to deliver a self-expanding stent to the iliac artery, superficial femoral arteries and / or proximal popliteal arteries to improve luminal diameter. The self-expanding stent is composed of nickel titanium alloy (nitinol); contains a total of 12 tantalum / gold radiopaque markers and imparts an outward radial force on the luminal surface of the vessel to establish patency.


Outcome Measures
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Primary Outcome Measures :
  1. Patency rate [ Time Frame: 12 (365 ± 30 days) months ]
    patency rate after one year defined as absence of clinically driven TLR (due to symptoms and drop of ABI of ≥ 20% or > 0.15 when compared to post-procedure baseline) or restenosis with PVR > 2.4 evaluated by Duplex Ultrasound

  2. Procedure-related death [ Time Frame: 12 (365 ± 30 days) months ]
    Composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization。


Secondary Outcome Measures :
  1. TLR rate at 6 and 12months [ Time Frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months ]
    The ratio of either repeat percutaneous or surgical revascularization for target lesions

  2. Sustained clinical improvement [ Time Frame: 12 (365 ± 30 days) months ]
    an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.

  3. WIQ at 6 and 12 months [ Time Frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months ]
    Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline

  4. Duplex-defined binary restenosis (PSVR >2.4) at 6 and 12 months or at any time of re-intervention [ Time Frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months ]
    Duplex-defined binary restenosis (PSVR >2.4) of the target lesion post-procedure and at 6 and 12 months or at any time of re-intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patient is ≥ 18 years old at the time of consent. 2. Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments.

    3. Rutherford Classification Category 2-4. Subjects with Rutherford Class 2 have gone through a conservative therapy without success. 4. De novo stenotic, restenotic or occlusive lesion(s) located in the superficial femoral artery and/or proximal popliteal artery (P1 segment) suitable for stenting after PTA.

    5. Lesion location starts distal to CFA bifurcation (below origin of deep femoral artery) and should not extend beyond the P1 segment of the popliteal artery.

    6. Lesion(s) is/are located at least 2 cm from any stent if target limb was already previously stented.

    7. >70 % diameter stenosis or occlusion by visual angiographic estimate. 8. Patent inflow (treatment of inflow is allowed before treatment of the target lesion if successful).

    9. Patent ipsilateral popliteal artery (P2 and P3 segments) and at least 1 patent infrapopliteal artery in continuity to ankle. 10. Target reference vessel diameter ≥ 4 - ≤ 7.0 mm.

Exclusion Criteria:

  • Patients will be excluded from the registry if any of the following criteria is met:

    1. Target Lesion previously tested with a stent or surgery.
    2. Rutherford Classification Category 0, 1, 5 or 6.
    3. Inability to tolerate antithrombotic or antiplatelet therapies.
    4. Known allergy or contraindication to contrast medium that, in the opinion of the investigator, can't be adequately pre-medicated.
    5. Non-dilatable severely calcified lesion.
    6. Known hypersensitivity to nitinol and/or its components (e.g. nickel, titanium).
    7. Acute or subacute thrombus in the target lesion.
    8. Documented life expectancy < 13 months
    9. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding.
    10. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
    11. Myocardial infarction or stroke within 90 days prior to index procedure.
    12. Hypercoagulable state.
    13. Patient is currently enrolled in any other clinical investigational trial(s).
    14. Use of alternative therapy in target lesion during index procedure, e.g. atherectomy, lysis therapy, laser therapy, DES, re-entry-devices, cutting / scoring balloon
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751527


Contacts
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Contact: Summer Zheng, Bachelor +8613601399119 summer.zheng@zyloxmedical.com
Contact: Jie Liang, Bachelor +8613819565660 jie.liang@zyloxmedical.com

Locations
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Germany
Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin Recruiting
Halle, Germany, 06114
Contact: Corneliu Gheorghe, Phd. med    +49(0)345 778 6344      
Principal Investigator: Corneliu Gheorghe         
Sponsors and Collaborators
Zhejiang Zylox Medical Device Co., Ltd.
Investigators
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Study Director: Dierk Scheinert Universitätsklinikum Leipzig
Principal Investigator: Annett Glanz Diakoniekrankenhaus Halle
More Information
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Responsible Party: Zhejiang Zylox Medical Device Co., Ltd.
ClinicalTrials.gov Identifier: NCT03751527    
Other Study ID Numbers: 201805
First Posted: November 23, 2018    Key Record Dates
Last Update Posted: August 31, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases