Peripheral Arterial DiseaseNCT07049120
Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions
A study testing ZENFLEX Pro™ Peripheral Drug-eluting Stent System in people with Peripheral Arterial Disease, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in Poland.
Trial summary
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- ZENFLEX Pro™ Peripheral Drug-eluting Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 sitePoland
- Study dates
- 30 Jun 2025to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Inclusion Criteria:
- Aged 18 to 80 years, regardless of gender.
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5.
- Subject (or legal guardian, if applicable) is willing and able to provide consent before to the performance of any study-specific tests or procedures, has signed the consent form and agrees to attend all required follow-up visits.
- Angiographic Inclusion Criteria:
- Stenotic, restenotic or occlusive lesion(s) located in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) (i.e., within the P1 segment):
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- Degree of stenosis ≥70% by visual angiographic assessment.
- Vessel diameter ≥4.0 mm and ≤6.5 mm.
- Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
- Chronic total occlusion with a total lesion length of ≤120 mm.
- Patent popliteal and infrapopliteal arteries, with single-vessel runoff or better, defined as at least one of the three vessels remaining patent (i.e., <50% stenosis) down to the ankle or foot.
Who cannot join
- Clinical exclusion criteria:
- Pregnant or breastfeeding women, or women/men planning to conceive.
- Subjects who have had or are planned for major amputation (at or above the ankle level).
- Subjects known to be allergic or intolerant to materials used in the investigational device or treatment drugs, including nitinol, paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, contrast agents, etc.
- Subjects with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.
- Subjects with known, uncorrectable hemorrhagic disorders or severe coagulation dysfunction (prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≥2 times the upper limit of normal, or platelet count <80×10⁹/L).
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- Previously stented target lesion/vessel.
- Target lesion/vessel previously treated with drug-coated balloon <12 months prior to enrollment.
- Subjects with a life expectancy of less than 1 year.
- Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.
- Subjects diagnosed with major clinical diseases or unstable conditions within the past 3 months, such as severe heart failure, unstable angina, myocardial infarction, transient ischemic attack or stroke, severe neurological or psychiatric history, severe infections, gastrointestinal bleeding, or active disseminated intravascular coagulation.
- Subjects currently participating in another clinical trial involving drugs or medical devices.
- Subjects whom the investigator considers unsuitable for participation in the clinical trial.
- Angiographic exclusion criteria:
- Presence of aneurysm in the target vessel.
- Heavily calcified lesions (Peripheral Arterial Calcium Scoring System [PACSS] grades 3-4).
- The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.
- The guidewire cannot pass through the target lesion, or percutaneous transluminal angioplasty (PTA) balloon cannot be used for pre-dilation.
- Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
American Heart of Poland, Małopolskie Cardiovascular Center PAKS Chrzanów
Chrzanów, Chrzanów, 32-500
Przemysław Nowakowski, MD, +48 32 625 81 20, nowakowski.mcsn@gmail.co
About this study
Official title: Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months. The primary endpoint is primary patency at 12 months.
Read the detailed description
This is a prospective, multi-center, single-arm, post-market registry study designed to ensure continued evaluation of real-world safety, performance and efficacy of the ZENFLEX Pro™ Peripheral Drug-eluting Stent System in the treatment of femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be enrolled in this study. Follow-up visits will be scheduled at 1-, 6-, and 12-months post-procedure. The primary endpoint is primary patency at 12 months. Secondary endpoints include technical success, procedural success, secondary patency rate, target lesion revascularization (TLR), clinically driven target lesion revascularization (CD-TLR), Rutherford classification, and ankle-brachial index (ABI). Safety endpoints include major adverse events, adverse events, all-cause mortality, major amputations, minor amputations, and stent fractures.
- Conditions
- Peripheral Arterial Disease
- Being tested
- ZENFLEX Pro™ Peripheral Drug-eluting Stent System
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZENFLEX Pro™ Peripheral Drug-eluting Stent SystemDevice
The ZENFLEX Pro™ Peripheral Drug-eluting Stent System will be implanted in patients with femoropopliteal artery lesions to evaluate safety and efficacy outcomes. The device is designed to provide mechanical support and deliver antiproliferative drug locally to reduce restenosis. The procedure will be performed via standard endovascular techniques.
| Study group | Role | What they receive |
|---|---|---|
| ZENFLEX Pro | Experimental | Subjects in this arm will receive treatment with the ZENFLEX Pro™ Peripheral Drug-eluting Stent System for femoropopliteal artery stenosis or occlusion. The procedure will be performed according to the device's instructions for use (IFU). Follow-up assessments will be conducted at 1, 6, and 12 months post-procedure to evaluate safety, efficacy, and performance outcomes. Receives: Device: ZENFLEX Pro™ Peripheral Drug-eluting Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reaching Primary Patency
Primary patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit in the absence of clinically driven TLR or bypass of the target lesion.
Measured: 12 months post-procedure
Secondary outcomes (8)
Number of participants with successful stent delivery and deployment resulting in ≤30% residual stenosis
Technical success is defined as the delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually.
Measured: During the procedure
Number of participants with procedural success (technical success and no MAEs within 24 hours)
Procedural success is defined as technical success with no major adverse events (MAEs) noted within 24 hours of the index procedure.
Measured: Within 24 hours post-procedure
Number of participants with primary patency
Primary patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit in the absence of clinically driven TLR or bypass of the target lesion.
Measured: 6 months post-procedure
Number of participants with secondary patency
Secondary patency at 6 months and 12 months. Secondary patency is defined as the absence of restenosis in the target lesion on DUS follow-up, with a diameter stenosis of ≤50% (PSVR ≤2.4), regardless of whether the target lesion has undergone reintervention.
Measured: 6 and 12 months post-procedure
Number of participants undergoing target lesion revascularization (TLR)
TLR is defined as any repeat revascularization (endovascular or surgical) of the target lesion due to restenosis or occlusion, regardless of symptoms or diagnostic findings.
Measured: At 1, 6, and 12 months post-procedure
Clinically Driven Target Lesion Revascularization (CD-TLR)
A target lesion revascularization will be considered clinically driven if it occurs within 5 mm proximal or distal to the original treatment segment with diameter stenosis ≥50% by quantitative angiography (QA) and the subject has recurrent symptoms (≥1 change in Rutherford Classification or associated with decreased ABI/TBI of ≥20% or ≥0.15 in the treated segment. TBI allowed in cases of incompressible vessels.)
Measured: At 1, 6, and 12 months post-procedure
Change in Rutherford Classification at 1, 6, and 12 months
Rutherford Peripheral Arterial Disease (PAD) Classification is a clinical grading system used to assess the severity of lower limb ischemia. The scale ranges from 0 to 6, where higher scores indicate more severe disease. Each category is defined by clinical symptoms and objective hemodynamic criteria as follows:
0: Asymptomatic - Normal treadmill or stress test
- Mild claudication - Completes treadmill test; post-exercise ankle pressure (AP) <50 mmHg, and >25 mmHg drop from resting blood pressure
- Moderate claudication - Symptoms between categories 1 and 3
- Severe claudication - Cannot complete treadmill test; post-exercise AP <50 mmHg
- Ischemic rest pain - Resting AP <40 mmHg, with flat or low-amplitude ankle/metatarsal pulse volume recording (PVR); toe pressure (TP) <30 mmHg
- Minor tissue loss - Non-healing ulcer or localized gangrene with edema; resting AP <60 mmHg, ankle or metatarsal PVR flat or low amplitude; TP <40 mmHg
- Major tissue loss - Tissue loss extendi
Measured: 1, 6, and 12 months post-procedure
Change in Ankle-Brachial Index (ABI) from baseline at 1, 6, and 12 months
The ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:
Ankle: The systolic pressure will be measured in the target limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.
Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.
Measured: 1, 6, and 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Liu, Study director, Zhejiang Zylox Medical Device Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049120
- Sponsor's protocol ID
- CE-02
- Status last verified
- Jun 2025
- First submitted
- 16 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
- ClinicalTrials.gov ID
- NCT07049120
- Acronym / sponsor ID
- CE-02
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Zhejiang Zylox Medical Device Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 3 Jul 2025 (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.
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months. The primary endpoint is primary patency at 12 months.
Detailed description
This is a prospective, multi-center, single-arm, post-market registry study designed to ensure continued evaluation of real-world safety, performance and efficacy of the ZENFLEX Pro™ Peripheral Drug-eluting Stent System in the treatment of femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be enrolled in this study. Follow-up visits will be scheduled at 1-, 6-, and 12-months post-procedure. The primary endpoint is primary patency at 12 months. Secondary endpoints include technical success, procedural success, secondary patency rate, target lesion revascularization (TLR), clinically driven target lesion revascularization (CD-TLR), Rutherford classification, and ankle-brachial index (ABI). Safety endpoints include major adverse events, adverse events, all-cause mortality, major amputations, minor amputations, and stent fractures.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZENFLEX Pro | Experimental | Device: ZENFLEX Pro™ Peripheral Drug-eluting Stent SystemSubjects in this arm will receive treatment with the ZENFLEX Pro™ Peripheral Drug-eluting Stent System for femoropopliteal artery stenosis or occlusion. The procedure will be performed according to the device's instructions for use (IFU). Follow-up assessments will be conducted at 1, 6, and 12 months post-procedure to evaluate safety, efficacy, and performance outcomes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical Inclusion Criteria:
- Angiographic Inclusion Criteria:
Key exclusion criteria (19 listed)
- Clinical exclusion criteria:
- Angiographic exclusion criteria:
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 Pro™ Peripheral Drug-eluting Stent SystemThe ZENFLEX Pro™ Peripheral Drug-eluting Stent System will be implanted in patients with femoropopliteal artery lesions to evaluate safety and efficacy outcomes. The device is designed to provide mechanical support and deliver antiproliferative drug locally to reduce restenosis. The procedure will be performed via standard endovascular techniques. | Device | ZENFLEX Pro |
Primary outcome
Number of Participants Reaching Primary Patency
Time frame: 12 months post-procedure
Primary patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit in the absence of clinically driven TLR or bypass of the target lesion.
8 secondary outcomes
Number of participants with successful stent delivery and deployment resulting in ≤30% residual stenosis
Time frame: During the procedure
Number of participants with procedural success (technical success and no MAEs within 24 hours)
Time frame: Within 24 hours post-procedure
Number of participants with primary patency
Time frame: 6 months post-procedure
Number of participants with secondary patency
Time frame: 6 and 12 months post-procedure
Number of participants undergoing target lesion revascularization (TLR)
Time frame: At 1, 6, and 12 months post-procedure
Clinically Driven Target Lesion Revascularization (CD-TLR)
Time frame: At 1, 6, and 12 months post-procedure
Change in Rutherford Classification at 1, 6, and 12 months
Time frame: 1, 6, and 12 months post-procedure
Change in Ankle-Brachial Index (ABI) from baseline at 1, 6, and 12 months
Time frame: 1, 6, and 12 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- 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.
Tao Liu study director
Zhejiang Zylox Medical Device Co., Ltd.
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 Pro™ Peripheral Drug-eluting Stent System in people with Peripheral Arterial Disease, run by Zhejiang Zylox Medical Device Co., Ltd. at 1 site in Poland.
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 11 inclusion and 19 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: opening soon, as of the sponsor's last update on 3 Jul 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Przemysław Nowakowski (+48 32 625 81 20, nowakowski.mcsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reaching Primary Patency (time frame: 12 months post-procedure). 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 3 Jul 2025.