HORIZON Prospective Clinical Investigation

Qmedics

Status: Terminated

Conditions: Peripheral Arterial Disease

Treatments: Device: EXIST 6F NiTi Stent System PULL; Device: EXIST 6F NiTi Stent System FLEX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05234164

120884

Details and patient eligibility

About

The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX & PULL in a prospective investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in Peripheral Artery Disease (PAD) requiring treatment of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment).

Full description

This is a multicenter, prospective study with clinical and radiographic follow-up for 24 months months post-procedure. Approximately two hundred thirty subjects will be enrolled (115 subjects will receive the FLEX type and 115 subjects the PULL type) in several centers, minimum 10 patients per investigational center. All patients will be evaluated at 30 days and 6-, 12- and 24-months post-index procedure.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 2 patient groups

EXIST 6F NiTi Stent System FLEX

Experimental group

Description:

Stent implantation of lesions in the SFA graded with Fanelli 1 and 2, and lesions in the P1 segment of the proximal popliteal artery.

Treatment:

Device: EXIST 6F NiTi Stent System FLEX

EXIST 6F NiTi Stent System PULL

Experimental group

Description:

Stent implantation of lesions in the SFA graded with 3 and 4.

Treatment:

Device: EXIST 6F NiTi Stent System PULL