Evaluation of Paclitaxel Eluting Stent vs Paclitaxel Eluting Balloon Treating Peripheral Artery Disease of the Femoral Artery

Study Overview
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Brief Summary
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Objective of the REAL PTX trial is to compare paclitaxel-eluting stents to paclitaxel-eluting balloons for treating symptomatic peripheral artery disease of the femoropopliteal artery.

Detailed Description
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The REAL PTX trial has been designed as prospective, randomized, multi-center, post-market study investigating the effect of the paclitaxel-eluting stent Zilver® PTX® (DES)in comparison to the use of a paclitaxel eluting balloon (DEB)in treating symptomatic peripheral artery disease of the femoropopliteal artery. Up to 150 patients will be enrolled in Germany and Belgium. Enrollment is expected to be completed within approximately six months of initiating the study. One group (DES or DEB) will be considered to yield significantly better results of the primary patency rate than the other group at 12 months follow up.

Official Title
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REAL PTX - Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Paclitaxel Eluting Stent
* Device: Paclitaxel Eluting Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject age ≥ 18 Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form. Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing. Rutherford category 2-5. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion. Target lesion is at least 1cm below the origin of the profunda femoris and does not exceed the medial femoral epicondyle. A single target lesion (stenotic areas separated by more than 3 cm with ≤ 30% stenosis might, at the decision of the investigator, be considered as 2 lesions). Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual assessment. Patency of at least one (1) infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery. A guidewire has successfully traversed the target treatment segment. Exclusion Criteria: Clinical exclusion criteria Inability to obtain informed consent. Life expectancy < 12 months. Pregnancy, suspected pregnancy, or breastfeeding during study period (patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment). Presence of one or more of the following co-morbid factors: hemodialysis dependence, renal insufficiency with a serum creatinine ≥ 2.5 mg/dl, cerebrovascular accident (CVA) within 1 month of procedure or any CVA resulting in unresolved walking impairment, and/or myocardial infarction (MI) within 1 month of procedure. Any evidence of hemodynamic instability prior to procedure/randomization. Coagulopathy or clotting disorders. Present or suspected systemic infection or osteomyelitis affecting target limb. Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytics, etc). Hypersensitivity to nitinol and/or paclitaxel. Enrollment into another study. Intervention of the target lesion less than 90 days prior of the study procedure. Anatomic Exclusion Criteria: Untreated external iliac artery inflow lesion (study allows for successful treatment prior to study treatment procedures). Total occlusion uncrossable by a conventional guidewire. Acute occlusive intraluminal thrombosis of the proposed lesion site. Evidence of an aneurysm at the target lesion site. Perforation in the target vessel as evidenced by the extravasation of contrast.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel Eluting Stent<br>Patients randomized to treatment with paclitaxel eluting stent will receive the Zilver® PTX® stent.Primary stenting should be performed covering the full lesion. Post-dilatation is at the investigator's discretion. | Device: Paclitaxel Eluting Stent<br> <br> * Other names: Zilver PTX stent;|
| Active Comparator: Paclitaxel Eluting Balloon<br>For patients randomized to treatment with drug eluting balloon (DEB), angioplasty (ballooning) should be performed covering the full lesion. | Device: Paclitaxel Eluting Balloon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Systolic Velocity Ratio (PSVR) | The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) > 2.4 as evaluated by duplex ultrasound core laboratory analysis. | 12 months | 
| target lesion revascularization (TLR) | The primary outcome will be the one-year primary patency rate (Kaplan-Meier estimate at 12 months).Primary patency is defined as absence of clinically-driven target lesion revascularization (TLR) or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) > 2.4 as evaluated by duplex ultrasound core laboratory analysis. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Events (MAEs) | MAE is defined as: Death within 30 days of the index procedure or within 30 days of a target lesion revascularization (TLR) Clinically-driven TLR, or Major target limb amputation. | 6, 12 and 24 months | 
| All cause death |  | 6, 12 and 24 months | 
| Target vessel revascularization (TVR) |  | 6, 12 and 24 months | 
| Clinically-driven target lesion revascularization (TLR) | Clinically-driven TLR is defined as a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral artery disease (PAD) following the initial procedure. | 6, 12 and 24 months | 
| Major target limb amputation within 6, 12 and 24 months. Major target limb Major target limb amputation | Major target limb amputation is defined as amputation of the target leg other than amputation of the toe(s). | 6, 12 and 24 months | 
| Sustained clinical improvement | Sustained clinical improvement is defined as an improvement in the Rutherford category of one class compared to baseline in surviving patients who are free from major target limb amputation and free from target lesion revascularization (TLR). | 6, 12 and 24 months | 
| Binary restenosis | Binary restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)of the target lesion at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point. | 6, 12 and 24 months | 
| Walking capacity | Walking capacity assessment by walking impairment questionnaire (WIQ) at 6, 12 and 24 months or at the time of reintervention prior to any pre-specified time point. | 6, 12 and 24 months | 
| Procedural success | Procedural success is defined as obtainment of < 30% residual stenosis on angiography by visual estimate. | 6, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, stenting, angioplasty