Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System

Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System for the Treatment of Peripheral Arterial Disease in the Vasculature of the Lower Limbs

The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the peripheral vasculature of the lower limbs.

General Inclusion Criteria:

1. Rutherford Clinical Category (RCC) Score of 2 - 5

2. Willing and capable of complying with all follow-up evaluations at the specified times

3. Age ≥ 18 years old

4. Provides written informed consent prior to study specific procedures

5. Completed Ankle/Brachial Index (ABI) (or Toe/Brachial Index [TBI]) prior to index procedure (up to 60 days prior)

   Angiographic Inclusion Criteria:

6. Evidence of ≥ 70% stenosis or occlusion in the peripheral vasculature of the target vessel, confirmed by angiography

7. Target lesion present in a single limb that consists of a single de novo or non-stented restenotic lesion, or qualifies as a tandem or combination lesion per the definitions below:

   1. Tandem (adjacent) Lesion: Lesions present in the same target vessel that can be treated as one single lesion and is separated by an angiographic normal vessel ≤3 cm at any point. Multiple points of separation can be present in single lesion treatment if no single point of separation is > 3 cm
   2. Combination Lesion: A single lesion that is not completely occluded but includes a segment of complete occlusion anywhere along the length

8. Exchangeable guidewire must cross target lesion within the lumen

9. Total target lesion length is ≥ 20 mm and ≤ 200mm

10. Reference vessel diameter (RVD) is ≥ 2.0 mm and ≤ 5.0 mm

11. Identifiable distal target vessel which upon completion of the intervention is anticipated to provide reconstitution of blood flow to the foot. Angiographic evidence of adequate distal runoff through the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal artery] is patent, defined as < 50% stenosed)

12. Multiple lesions in the target limb (including the target lesion and non-target lesions) may be treated if all of the following applies:

    1. Non-target lesion(s) must be located proximal to the target lesion
    2. Non-target lesion(s) must be successfully treated (defined as optimally treated [e.g. no untreated arterial dissections or perforation present]) by standard endovascular procedures prior to initiation of treatment of the target lesion
    3. Non-target lesions treated prior to target lesion cannot be treated with rotational, orbital or laser atherectomy
    4. Non-target lesion(s) may be located in separate vascular beds (i.e., iliac,femoropopliteal, tibial) or multiple tibial vascular beds (i.e., anterior tibial, posterior tibial, tibioperoneal trunk/peroneal). (Note: Only one tibial vessel may be identified as the target vessel with the target lesion.)
    5. Only one lesion per the above definitions may be treated as the target lesion with the Axys EX device

    General Exclusion Criteria:

13. Has one or more of the contraindications listed in the Axys EX Rotational Atherectomy System's IFU

14. Contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug anticipated to be used

15. Hypersensitivity to contrast material that cannot be adequately pretreated

16. Known uncontrollable hypercoagulable condition or refuses blood transfusion

17. Life expectancy of less than 12 months

18. Surgical (requiring hospitalization) or endovascular intervention of the target limb within 30 days prior to the index procedure

19. Planned surgical intervention or endovascular procedure within 30 days after the index procedure

20. Currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints

21. Other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention

22. If a previous peripheral bypass affecting the target limb is present, the bypass must be patent and the target lesion cannot be present in the peripheral bypass artery

23. Impaired renal function (defined as GFR < 30 mL/min) or on dialysis

24. Recent myocardial infarction or stroke ≤ 30 days prior to the index procedure

25. Previous or planned amputation above the metatarsal line on the target limb

26. Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. Patient must be able to consent for themselves

27. Patient is pregnant (female patients of child-bearing potential must have a pregnancy test done within 7 days prior to the index procedure)

    Angiographic Exclusion Criteria:

28. Noted thrombus at the point of the intended target lesion

29. In-stent restenosis of the target lesion

30. Aneurysmal target vessel

31. Hemodynamic significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel

32. Perforation, flow limiting dissection or other injury of the target vessel requiring surgical intervention prior to enrollment

33. Disease that precludes safe advancement of the Axys EX device to the target lesion

34. Need to treat a lesion distal to the target index lesion