Belgian Study to Assess the Efficacy and Safety of the RESTORER Iliac Stent for Treatment of Aorto-iliac Lesions. (BARISTA)

This is an interventional treatment trial for Peripheral Arterial Disease Read More

Inclusion Criteria: 1. Males or non-pregnant females ≥ 18 years of age at the time of consent. Females of childbearing potentials have a negative pregnancy test <7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female participants will be exempted from this requirement in case they are sterile, infertile or have been post-menopausal for at least 12 months.

2. Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study.

3. Patient presenting with a stenotic or occlusive lesion at the Aorto-iliac arteries suitable for stenting with the Restorer stent (iVascular) (on indication for primary stenting, based on the discretion of the investigator). This lesion is corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.

4. Estimated life expectancy ≥ 2 years. 5. Patient presenting a score from 2 to 4 following Rutherford classification. 6. Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study.

7. The target lesion has angiographic evidence of stenosis or restenosis >50% or occlusion which can be passed with standard guidewire manipulation.

8. There is angiographic evidence of a patent Common and Deep Femoral Artery.

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Exclusion Criteria: 1. Patients with a history of coagulation disorders, 2. Presence of an aneurysm immediately adjacent of the site of stent implantation, 3. Extension of more than 1cm in distal aorta, 4. Extension into CFA, 5. Fresh thrombus formation, 6. Acute limb ischemia, defined as symptom onset during less than 14 days prior to the index procedure, 7. Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12.000/or febrile state or CRP>5mg/L, 8. Existing stent implant in the target vessel, 9. Use of alternative therapies: atherectomy, cutting/scoring balloons, laser, … 10. Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80.000/µL or greater than 500.000/µL, 11. Any subject in which antiplatelet, anticoagulant or thrombolytic therapy is contraindicated, 12. Known hypersensitivity or contraindication to the stent material (CoCr L605), 13. Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up, 14. Known hypersensitivity or allergy to contrast agents that cannot be medically managed, 15. Inadequate inflow lesion treatment (>30% residual stenosis), 16. Subject has IFU listed contraindication(s).

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