HORIZON Prospective Clinical Investigation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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HORIZON. Clinical Investigation of the Qmedics EXIST NiTi Stent Type FLEX & PULL in Adults With Peripheral Artery Disease (PAD)

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: EXIST 6F NiTi Stent System FLEX
* Device: EXIST 6F NiTi Stent System PULL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Clinical: Patient age 18 years or older 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 Symptoms of peripheral arterial disease classified as Rutherford Category 2, 3 or 4 or Fontaine Class IIb or III The stenotic or occlusive lesion in Superficial Femoral Artery (SFA) and proximal popliteal artery, P1 segment, is considered suitable for stenting No underlying medical condition is present which would prevent the subject from performing the required testing or from completing the study. Stable medical condition Anatomical criteria: Included TASC II, A-B-C measured on pre- angio CT-scan (if CT-scan is standard of care) 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 Patent ipsilateral iliac, popliteal (P2 and P3) and at least one tibial vessel Exclusion Criteria: - Clinical criteria: Subjects pregnant, breastfeeding or planning to become pregnant during the trial participation Documented life expectancy less than 24 months due to other medical co-morbid condition(s) Thrombophlebitis or deep vein thrombosis within the past 30 days. Unable to assume DAPT (Dual Antiplatelet Therapy) Concomitant renal failure with serum creatinine level > 2.5 mg/dL (or > 220 µmol/L) or GFR < 30 ml/min/1,73 m2 Unresolved neutropenia (white blood cell count < 3,000 / µL) or thrombocytopenia (platelet count < 80,000 / µL) at the time of the index procedure Unresolved bleeding disorder (INR ≥ 1.2) at the time of the index procedure Active gastrointestinal bleeding Anticoagulation therapy for other medical condition Anatomical criteria: 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) Previously stented ipsilateral SFA Prior peripheral vascular bypass surgery involving the target limb(s) Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion Target lesion requires the use of cutting balloons, atherectomy or drug coated balloons (DCB) during the intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2, and subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent type FLEX. Subject graded with Fanelli 3 and 4 will be treated with the Exist 6F NiTi Stent PULL.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXIST 6F NiTi Stent System FLEX<br>Stent implantation of lesions in the SFA graded with Fanelli 1 and 2, and lesions in the P1 segment of the proximal popliteal artery. | Device: EXIST 6F NiTi Stent System FLEX<br>* Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent FLEX type. Subjects requiring treatment of the SFA will undergo an additional calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2 will be treated with the Exist 6F NiTi Stent FLEX type.<br>|
| Experimental: EXIST 6F NiTi Stent System PULL<br>Stent implantation of lesions in the SFA graded with 3 and 4. | Device: EXIST 6F NiTi Stent System PULL<br>* Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli grade 3 and 4 will be treated with the Exist 6F NiTi Stent PULL type.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency | The primary patency rate (defined as freedom from more than ≥ 50% restenosis) at 12 months post-procedure as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr ≥ 2,5 suggests a reduction in the luminal diameter >50%. | 12 months | 
| Major Adverse Events | Freedom from procedure- or stent-related Major Adverse Events (MAEs) at 30-days post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Rutherford / Fontaine classification | Clinical success Defined as improvement of Rutherford / Fontaine classification of one class or more as compared to the pre-procedure and an ankle-brachial index improvement (ABI) by ≥ 0.15. | 6- and 12-months | 
| Primary patency | Compare the Exist 6F NiTi stent primary patency with >50% of subjects with peripheral artery disease with literature data. | 12-months | 
| Rate of stent fracture | Stent fracture rate is evaluated with x-ray. Stent fracture is defined according to classification on x-ray. | 12- and 24-months | 
| Freedom from Target Lesion Revascularization | Defined as the absence of revascularization (by any means) of the target lesion (fTLR). | 1 month, 6-, 12- and 24-months | 
| Walking and mobility | Improvement of walking and mobility is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline. | 1 month, 6-, 12- and 24-months | 
| Patency rate | Patency rate as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr ≥ 2,5 suggests a reduction in the luminal diameter >50%. | 24 months | 
| Major Adverse Events | Procedure- or stent-related Major Adverse Events (MAEs) post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stenotic lesions, Peripheral Arterial Disease, occluded lesions, Superficial Femoral Artery, nitinol stent, self-expanding stent, Chronic Limb-Threatening Ischemia