Status:
UNKNOWN
ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty
Lead Sponsor:
Zhejiang Zylox Medical Device Co., Ltd.
Conditions:
Atherosclerosis of Femoral Artery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 an...
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 patient...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
December 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03751527
Start Date
December 31 2018
End Date
December 1 2023
Last Update
August 31 2021
Active Locations (1)
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1
Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin
Halle, Germany, 06114