Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions

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• Peripheral Arterial Disease 1,542

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's planned enrollment of 153 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Lead sponsor

Zhejiang Zylox Medical Device Co., Ltd. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  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.

  Device: ZENFLEX Pro™ Peripheral Drug-eluting Stent System

Interventions

• DeviceZENFLEX Pro™ Peripheral Drug-eluting Stent System

  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.

Primary outcomes

1. 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.

   Time frame: 12 months post-procedure

Secondary outcomes

1. 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.

   Time frame: During the procedure

2. 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.

   Time frame: Within 24 hours post-procedure

3. 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.

   Time frame: 6 months post-procedure

4. 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.

   Time frame: 6 and 12 months post-procedure

5. 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.

   Time frame: At 1, 6, and 12 months post-procedure

6. 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.)

   Time frame: At 1, 6, and 12 months post-procedure

7. 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 1. Mild claudication - Completes treadmill test; post-exercise ankle pressure (AP) \<50 mmHg, and \>25 mmHg drop from resting blood pressure 2. Moderate claudication - Symptoms between categories 1 and 3 3. Severe claudication - Cannot complete treadmill test; post-exercise AP \<50 mmHg 4. Ischemic rest pain - Resting AP \<40 mmHg, with flat or low-amplitude ankle/metatarsal pulse volume recording (PVR); toe pressure (TP) \<30 mmHg 5. 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 6. Major tissue loss - Tissue loss extendi

   Time frame: 1, 6, and 12 months post-procedure

8. 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.

   Time frame: 1, 6, and 12 months post-procedure

Individual participant data

Plan to share: No