Atherosclerosis of Femoral ArteryNCT03751527
ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty
A study testing ZENFLEX peripheral stent system in people with Atherosclerosis of Femoral Artery, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis of Femoral Artery
- What is being tested?
- ZENFLEX peripheral stent system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 31 Dec 2018to Dec 2023
- 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
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin
Halle, 06114
Corneliu Gheorghe, Phd. med, +49(0)345 778 6344
Corneliu Gheorghe
About this study
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
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
Read the 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.
- Conditions
- Atherosclerosis of Femoral Artery
- Being tested
- ZENFLEX peripheral stent system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZENFLEX peripheral stent systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ZENFLEX stent Group | Experimental | subjects applying ZENFLEX peripheral stent system Receives: Device: ZENFLEX peripheral stent system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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。
Measured: 12 (365 ± 30 days) months
Secondary outcomes (4)
TLR rate at 6 and 12months
The ratio of either repeat percutaneous or surgical revascularization for target lesions
Measured: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Sustained clinical improvement
an improvement shift in the Rutherford classification of one class in amputation and TVR free surviving patients at 12 months.
Measured: 12 (365 ± 30 days) months
WIQ at 6 and 12 months
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 6 and 12 months vs. baseline
Measured: 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
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
Measured: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start31 Dec 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis of Femoral ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dierk Scheinert, Study director, Universitätsklinikum LeipzigAnnett Glanz, Principal investigator, Diakoniekrankenhaus Halle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751527
- Sponsor's protocol ID
- 201805
- Status last verified
- Aug 2021
- First submitted
- 21 Nov 2018
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03751527
- Acronym / sponsor ID
- 201805
- Conditions
- Atherosclerosis of Femoral Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZENFLEX stent Group | Experimental | Device: ZENFLEX peripheral stent systemsubjects applying ZENFLEX peripheral stent system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- Patients will be excluded from the registry if any of the following criteria is met:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZENFLEX peripheral stent systemThe 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. | Device | ZENFLEX stent Group |
Primary outcome
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
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。
4 secondary outcomes
TLR rate at 6 and 12months
Time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Sustained clinical improvement
Time frame: 12 (365 ± 30 days) months
WIQ at 6 and 12 months
Time frame: 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
Time frame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dierk Scheinert study director
Universitätsklinikum Leipzig
Annett Glanz principal investigator
Diakoniekrankenhaus Halle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZENFLEX peripheral stent system in people with Atherosclerosis of Femoral Artery, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in Germany.
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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Summer Zheng, Bachelor (+8613601399119, summer.zheng@zyloxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate (time frame: 12 (365 ± 30 days) months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2021.