Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA)- Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease

Study Overview
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Brief Summary
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This study postulates that the application of Sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via Sirolimus coated balloon (SCB) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (PAD). The aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal PAD.

Detailed Description
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It is imperative to have effective treatment strategies for PAD which can maintain the patency of arteries. The current standard of care for PAD is angioplasty which includes usage of drug coated balloons (DCB). Paclitaxel is the only anti-proliferative drug available in all currently available DCB technology. Sirolimus is another highly effective anti-proliferative drug of immense potential as demonstrated by superior results in Sirolimus drug eluting stents in coronary disease. The physical properties of Sirolimus have made it challenging for it to be similarly applied to DCB technology and it is only due to recent advances in nanotechnology that it is now possible to develop Sirolimus coated balloons (SCB), which is the study device used in this study. The study device allows delivery and deposition of sirolimus to the arterial wall. By applying this agent into lesions in peripheral arterial disease, this study aim to effectively reduce neointimal hyperplasia, and therefore prolong the patency of the artery and improve our limb salvage rates for PAD and CLI patients. Subjects will be followed up in the clinic at 6 month, 12 month, and 24 month post-intervention to assess primary and secondary outcome of safety and efficacy.

Official Title
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XTOSI Pilot Study: Clinical Use and Safety of the Xtreme Touch (Magic Touch PTA) - Neo Sirolimus Coated PTA Balloon Catheter in the Treatment of Infrainguinal Peripheral Arterial Disease

Conditions
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Peripheral Artery Disease, Atherosclerosis

Intervention / Treatment
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* Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 21 years or minimum age Subject must be willing to sign a Patient Data Release Form or Patient Informed Consent where applicable Lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the Xtreme Touch - Neo sirolimus PTA balloon catheter. For below the knee (BTK) arteries, lesions located in the proximal 200mm of the artery. Exclusion Criteria: Life expectancy ≤ 1 year Subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet Subject is pregnant or planning to become pregnant during the course of the study Failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty Failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Ages Eligible for Study
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Minimum Age: 21 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All-comers, real-world registry<br>Subjects requiring infrainguinal revascularization with the Xtreme Touch - Neo (Magic Touch PTA) | Device: Xtreme Touch - Neo sirolimus coated PTA balloon catheter<br>* The Xtreme Touch (Magic Touch PTA) - Neo Sirolimus PTA Balloon Catheter is the world's first sirolimus coated PTA balloon. The purpose of the X-TOSI all-comers registry is to collect short and long-term clinical performance data on the Xtreme Touch (Magic Touch PTA) -Neo sirolimus PTA balloon catheter in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in real world daily clinical practice.<br>* Other names: Magic Touch PTA - Sirolimus drug coated balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Number of Patients with Primary patency | Defined as by duplex ultrasonography-derived peak systolic velocity ratio of < = 2.4 | 6 months | 
| Safety: Number of Patients with Freedom from Major Adverse Events (MAE) defined as composite of | freedom from device- and procedure-related mortality, and major target limb amputation through to 30 days, and Freedom from clinically driven target lesion revascularization (TLR) within 6 months post-index procedure. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Freedom from clinically-driven TLR | Freedom From Clinically Driven Target Lesion Revascularization | 6, 12, and 24 months | 
| Number of Patients with Freedom from clinically-driven TVR | Freedom From Clinically Driven Target Vessel Revascularization | 6 and 24 months | 
| Number of Patients with Primary patency | Percentage of subjects with duplex ultrasound Clinical Primary Patency | 12 and 24 months | 
| Number of Patients with Freedom from MAE | b. A composite of freedom from device- and procedure-related mortality, and major target limb amputation | 12 and 24 months | 
| Number of Patients with Amputation-free survival | Amputation-free survival of patients | 6, 12 and 24 months | 
| Number of Patients with Improvement in Rutherford classification | Improvement in Rutherford classification compared to the pre-procedure Rutherford classification | 6, 12 and 24 months | 
| Number of Patients with Device success | Successful delivery, inflation, deflation, and retrieval of the Xtreme Touch - Neo balloon catheter. | Day 0 | 
| Number of Patients with Technical success | Successful completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter reduction of the treated lesion as determined by visual estimation | Day 0 | 
| Number of Patients with Procedural success | Participants will be followed for the duration of hospital stay, an expected average of 1-2 days | Participants will be followed for the duration of hospital stay, an expected average of 1-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PAD, BTK, SFA, DCB, SCB