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

NCT03751527 | Unknown DMC

• 1 other identifier: 201805
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Atherosclerosis of Femoral Artery

Outcome Measures

Primary Outcomes (2)

• Patency rate

  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

  12 (365 ± 30 days) months

• Procedure-related death

  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。

  12 (365 ± 30 days) months

Secondary Outcomes (4)

• TLR rate at 6 and 12months

  6 (182 ± 30 days) and 12 (365 ± 30 days) months

• Sustained clinical improvement

  12 (365 ± 30 days) months

• WIQ at 6 and 12 months

  6 (182 ± 30 days) and 12 (365 ± 30 days) months

• Duplex-defined binary restenosis (PSVR >2.4) at 6 and 12 months or at any time of re-intervention

  6 (182 ± 30 days) and 12 (365 ± 30 days) months

Study Arms (1)

ZENFLEX stent Group

EXPERIMENTAL

subjects applying ZENFLEX peripheral stent system

Device: ZENFLEX peripheral stent system

Interventions

ZENFLEX peripheral stent system DEVICE

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.

ZENFLEX stent Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Zylox Medical Device Co., Ltd.: lead

Study Sites (1)

Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin

Halle, 06114, Germany

RECRUITING

Study Officials

• Dierk Scheinert

  Universitätsklinikum Leipzig

  STUDY DIRECTOR

• Annett Glanz

  Diakoniekrankenhaus Halle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Summer Zheng, Bachelor

CONTACT

+8613601399119; summer.zheng@zyloxmedical.com

Jie Liang, Bachelor

CONTACT

+8613819565660; jie.liang@zyloxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 23, 2018
• Study Start: December 31, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)