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

Primary Purpose

Atherosclerosis of Femoral Artery

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

ZENFLEX peripheral stent system

About this trial

This is an interventional treatment trial for Atherosclerosis of Femoral Artery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere MedizinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ZENFLEX stent Group

Arm Description

subjects applying ZENFLEX peripheral stent system

Outcomes

Primary Outcome Measures

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

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。

Secondary Outcome Measures

TLR rate at 6 and 12months

The ratio of either repeat percutaneous or surgical revascularization for target lesions

Sustained clinical improvement

an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.

WIQ at 6 and 12 months

Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline

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

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

Full Information

NCT ID

NCT03751527

First Posted

November 21, 2018

Last Updated

August 29, 2021

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03751527

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

December 31, 2018 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis of Femoral Artery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ZENFLEX stent Group

Arm Type

Experimental

Arm Description

subjects applying ZENFLEX peripheral stent system

Intervention Type

Device

Intervention Name(s)

ZENFLEX peripheral stent system

Intervention Description

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.

Primary Outcome Measure Information:

Title

Patency rate

Description

Time Frame

12 (365 ± 30 days) months

Title

Procedure-related death

Description

Time Frame

12 (365 ± 30 days) months

Secondary Outcome Measure Information:

Title

TLR rate at 6 and 12months

Description

The ratio of either repeat percutaneous or surgical revascularization for target lesions

Time Frame

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

Title

Sustained clinical improvement

Description

an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.

Time Frame

12 (365 ± 30 days) months

Title

WIQ at 6 and 12 months

Description

Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline

Time Frame

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

Title

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

Description

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

Time Frame

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

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Summer Zheng, Bachelor

Phone

+8613601399119

summer.zheng@zyloxmedical.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Liang, Bachelor

Phone

+8613819565660

jie.liang@zyloxmedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dierk Scheinert

Organizational Affiliation

Universitätsklinikum Leipzig

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Annett Glanz

Organizational Affiliation

Diakoniekrankenhaus Halle

Official's Role

Principal Investigator

Facility Information:

Facility Name

Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin

City

Halle

ZIP/Postal Code

06114

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Corneliu Gheorghe, Phd. med

Phone

+49(0)345 778 6344

First Name & Middle Initial & Last Name & Degree

Corneliu Gheorghe

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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