Clinical investigation of the Qmedics EXIST NiTi Stent type Flex & Pull in adults with Peripheral Artery Disease (PAD) (of the Q-medics NiTi Stent Family. - HORIZO

QMedics AG0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•1. Patient age 18 years or older
•2. Subject is willing and able to provide consent before any study specific
•test or procedure is
•performed, signs the consent form, and agrees to attend all required follow-up
•3. Symptoms of peripheral arterial disease classified as Rutherford Category 2,
•3 or 4 or Fontaine
•Class IIb or III
•4. The stenotic or occlusive lesion in SFA and P1 is considered suitable for
•5. No underlying medical condition is present which would prevent the subject
•from performing
•the required testing or from completing the study.
•6. stable medical condition
•Anatomical criteria:
•7. Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is
•standard of care)
•8. Lesions must be one or multiple that can be treated with maximum two stents,
•maximum one
•overlapping and maximum length of the stent 25 cm *
•9. Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial

•Subjects are excluded if ANY of the following criteria are met:
•Clinical criteria:
•1. Subjects pregnant, breastfeeding or planning to become pregnant during the
•trial participation
•2. Documented life expectancy less than 24 months due to other medical
•co-morbid condition(s)
•3. Thrombophlebitis or deep vein thrombosis within the past 30 days.
•4. Impossibility in assuming DAPT
•5. Concomitant renal failure with serum creatinine level > 2.5 mg/dL (or > 220
•*mol/L) or
•GFR < 30 ml/min/1,73 m2HORIZON Confidential
•QME_HORIZON_CIP v1.0_01-oct-2019 page 15 of 52
•6. Unresolved neutropenia (white blood cell count < 3,000 / µL) or
•thrombocytopenia (platelet
•count < 80,000 / µL) at the time of the index procedure
•7. Unresolved bleeding disorder (INR >= 1.2) at the time of the index procedure
•8. Active gastrointestinal bleeding
•9. Anticoagulation therapy for other medical condition
•Anatomical criteria:
•10. Target lesion(s) received previous treatment within 30 days prior to
•enrolment (point of
•enrolment is defined as the time when the trial device enters the body)
•11. Previously stented ipsilateral SFA
•12. Prior peripheral vascular bypass surgery involving the target limb(s)
•13. Target lesion is located within an aneurysm or associated with an aneurysm
•in the vessel
•segment either proximal or distal to the target lesion
•14. Target lesion requires the use of cutting balloons, atherectomy or DCB
•during the intervention

发起方

QMedics AG