HORIZON Prospective Clinical Investigation

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring stenotic lesions, Peripheral Arterial Disease, occluded lesions, Superficial Femoral Artery, nitinol stent, self-expanding stent, Chronic Limb-Threatening Ischemia Read More

Inclusion Criteria:

- Clinical:

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 visits
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 Superficial Femoral Artery (SFA) and proximal popliteal artery, P1 segment, is considered suitable for stenting
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 vessel

Exclusion Criteria:

- 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. Unable to assume DAPT (Dual Antiplatelet Therapy)
5. Concomitant renal failure with serum creatinine level > 2.5 mg/dL (or > 220 µmol/L) or GFR < 30 ml/min/1,73 m2
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 drug coated balloons (DCB) during the intervention