Peripheral Arterial Disease
Conditions
Keywords
peripheral arterial disease
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.
Interventions
DEVICEPeripheral Drug-eluting Stent System
Drug-eluting stents (DES) are increasingly used in the treatment of PAD. These stentsare coated with antiproliferative drugs designed to provide mechanical support within the artery while releasing the drug gradually to reduce the risk of restenosis. Commonly used drugs include paclitaxel, sirolimus, and everolimus, which inhibit vascular smooth muscle cell proliferation, thereby reducing the likelihood of re-occlusion.
Sponsors
Zylox-Tonbridge Medical Technology Co., Ltd.
MDCECRO LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* (1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5. (3) 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: Eligible subjects must meet all of the following angiographic criteria: 1. 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): 1. Degree of stenosis ≥70% by visual angiographic assessment. 2. Vessel diameter ≥4.0 mm and ≤6.5 mm. 3. Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent). 4. Chronic total occlusion with a total lesion length of ≤120 mm. 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency at 12 months post-procedure | 12 Months | Primary vessel 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. |
Countries
Poland
Contacts
Primary ContactQiqing BO, Clinical Operations Manager
Outcome results
None listed