Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Number of Participants Reaching Primary Patency
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical Inclusion Criteria:
- •Aged 18 to 80 years, regardless of gender.
- •Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or
- •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):
- •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.
Exclusion Criteria
- •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).
- •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.
Arms & Interventions
ZENFLEX Pro
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.
Intervention: ZENFLEX Pro™ Peripheral Drug-eluting Stent System (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of participants with successful stent delivery and deployment resulting in ≤30% residual stenosis(During the procedure)
- Number of participants with procedural success (technical success and no MAEs within 24 hours)(Within 24 hours post-procedure)
- Number of participants with primary patency(6 months post-procedure)
- Number of participants with secondary patency(6 and 12 months post-procedure)
- Number of participants undergoing target lesion revascularization (TLR)(At 1, 6, and 12 months post-procedure)
- Clinically Driven Target Lesion Revascularization (CD-TLR)(At 1, 6, and 12 months post-procedure)
- Change in Ankle-Brachial Index (ABI) from baseline at 1, 6, and 12 months(1, 6, and 12 months post-procedure)
- Change in Rutherford Classification at 1, 6, and 12 months(1, 6, and 12 months post-procedure)