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

  • STATUS
    Recruiting
  • End date
    Dec 6, 2023
  • participants needed
    200
  • sponsor
    Zhejiang Zylox Medical Device Co., Ltd.
Updated on 6 September 2021

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

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.

Details
Condition Atherosclerosis of Femoral Artery
Treatment ZENFLEX peripheral stent system
Clinical Study IdentifierNCT03751527
SponsorZhejiang Zylox Medical Device Co., Ltd.
Last Modified on6 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. 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
0 mm

Exclusion Criteria

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