Clinical trial NCT03751527: ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty
Official title: ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atherosclerosis of Femoral Artery
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 and/or proximal popliteal artery (P1) lesions in patients with symptomatic peripheral artery disease

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 patients with de novo or restenotic lesion(s) of the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA, P1 segment) when used according to IFU. Up to 100 subjects will be enrolled in this study at up to 5 sites in Germany.

This study is a prospective, single-arm observational registry and does not include an active control arm. Therefore, no formal sample size calculation has been performed. All subjects will be evaluated at pre-discharge and during clinical follow-up visits 6 (182 ± 30 days) and 12 (365 ± 30 days) months post-procedure.

Primary endpoints are patency rate after one year and composite of freedom from device and procedure-related death through 12 months post procedure as well as freedom from both target limb major amputation and clinically-driven target lesion revascularization.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* Patients will be excluded from the registry if any of the following criteria is met:

  1. Target Lesion previously tested with a stent or surgery.
  2. Rutherford Classification Category 0, 1, 5 or 6.
  3. Inability to tolerate antithrombotic or antiplatelet therapies.
  4. Known allergy or contraindication to contrast medium that, in the opinion of the investigator, can't be adequately pre-medicated.
  5. Non-dilatable severely calcified lesion.
  6. Known hypersensitivity to nitinol and/or its components (e.g. nickel, titanium).
  7. Acute or subacute thrombus in the target lesion.
  8. Documented life expectancy \< 13 months
  9. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding.
  10. Other comorbidity risks which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
  11. Myocardial infarction or stroke within 90 days prior to index procedure.
  12. Hypercoagulable state.
  13. Patient is currently enrolled in any other clinical investigational trial(s).
  14. Use of alternative therapy in target lesion during index procedure, e.g. atherectomy, lysis therapy, laser therapy, DES, re-entry-devices, cutting / scoring balloon

Primary outcomes:
measure: Patency rate
timeFrame: 12 (365 ± 30 days) months
measure: Procedure-related death
timeFrame: 12 (365 ± 30 days) months
Secondary outcomes:
measure: TLR rate at 6 and 12months
timeFrame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
measure: Sustained clinical improvement
timeFrame: 12 (365 ± 30 days) months
measure: WIQ at 6 and 12 months
timeFrame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
measure: Duplex-defined binary restenosis (PSVR >2.4) at 6 and 12 months or at any time of re-intervention
timeFrame: 6 (182 ± 30 days) and 12 (365 ± 30 days) months
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Popescu Diakoniekrankenhaus Halle gGmbH Klinik für Innere Medizin
Study officials:
affiliation: Universitätsklinikum Leipzig
name: Dierk Scheinert
role: STUDY_DIRECTOR
affiliation: Diakoniekrankenhaus Halle
name: Annett Glanz
role: PRINCIPAL_INVESTIGATOR
References: