An Efficacy and Safety Study to Evaluate Ranger DEB for BTK Angioplasty in Patients With CLI (RANGER-BTK)

Study Overview
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Brief Summary
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Endovascular treatment of below the knee disease is a well-established therapy to improve outcomes in patients with critical limb ischemia. Several large cohort studies demonstrated the safety and the efficacy of percutaneous recanalization and angioplasty for distal vessel disease. A successful recanalization of foot artery was related to a higher ulcer healing and a reduction of major amputation. Moreover absence of revascularization in a patient with critical limb ischemia is an independent risk factor for mortality. Despite the introduction of new devices dedicated to below the knee vessel disease treatment, with the development of guides and conical balloons, long term patency outcomes are still poor. Restenosis was observed in more than two thirds of patients within 3 months after angioplasty of tibial arteries with a high target lesions revascularization. These re-interventions are characterized by a higher morbidity and mortality due to several comorbidities associated to these patients. These data confirm the need to obtain more lasting results in order to improve long-term outcomes of these patients. Recently, the use of drug-eluting balloons (DEB) has revealed an increase in patency after angioplasty of the femoral artery. On the contrary, results for BTK arteries angioplasty have shown controversial results. The purpose of this study is to evaluate the safety and the efficacy of the Ranger™ SL paclitaxel coated balloon a model of drug eluting balloon in patients with critical limb ischemia.

Official Title
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An Efficacy and Safety Study to Evaluate Ranger Drug-eluting Balloon for Below the Knee Angioplasty in Patients With Critical Limb Ischemia

Conditions
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Lower Limb Ischemia, Peripheral Vascular Diseases

Intervention / Treatment
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* Device: Ranger SL DEB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria : Age ≥18 years and ≤85 years Patient signed an approved consent form Patient has documented chronic Critical Limb Ischemia (CLI) in the target limb prior to the study procedure with Rutherford Category 4, 5 or 6 Menopausal or under contraception for women Negative serum β-HCG for women of childbearing age Angiographic Inclusion Criteria : Single or multiple lesions with ≥70% diameter stenosis (DS) of different lengths in one or more main below the knee vessels Intraluminal recanalization of the target lesion with successful traversal of the target lesion and placement of the guidewire into the distal true lumen Reference vessel reference diameter comprised between 2 and 4 mm Exclusion Criteria: General non-inclusion criteria: Patient with known hypersensitivity to paclitaxel Patient unwilling or unlikely to comply with Follow-Up schedule Life expectancy <1 year (investigator's appreciation) Planned major index limb amputation Pregnant or breast feeding women Angiographic exclusion criteria: Significant (≥50% DS) inflow lesion or occlusion in the ipsilateral iliac, superficial femoral or popliteal artery that cannot be treated successfully in the same session Previously implanted stent in the target lesions(s) Aneurysm in the target vessel Acute thrombus in the target limb Failure to cross the target lesion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ranger SL DEB angioplasty<br>patients filling general and angiographic inclusion/exclusion criteria will have an BTK angioplasty using one or several Ranger SL drug-eluting balloons | Device: Ranger SL DEB<br>* BTK angioplasty using Ranger SL DEB<br>* Other names: Ranger SL paclitaxel-eluting balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of deaths and major amputations | Number of deaths and major amputations (any amputation above the knee) at 6 months after procedure | 6 months | 
| Efficacy: Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) | Primary patency (no stenosis >50%) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of all death and major amputation | Number of deaths and major amputations (any amputation above the knee) at 12 months after procedure | 12 months | 
| Number of SAEs | Procedure related or contributed total number of SAEs | 12 months | 
| Number of AEs | Procedure related or contributed total number of AEs | 12 months | 
| Late Lumen Loss (LLL) | Late Lumen Loss (LLL) of the Target Lesion measured by Quantitative Vascular Angiography (QVA) | 6 months | 
| Clinically driven Target Lesion Revascularization (TLR) | Clinically driven TLR is defined as any TLR of the target lesion associated with Deterioration of Rutherford Class and/or increase in size of pre-existing wounds and / or occurrence of a new wound(s) | 6 and 12 months | 
| Amputation Free Survival |  | 6 and 12 months | 
| Rate of Wound Healing |  | 6 and 12 months | 
| Quality of Life | Quality of Life assessed by EQ5D questionnaires | 6 and 12 months | 
| Ulcer diameter | Ulcer diameter in the target limb | 1, 6 and 12 months | 
| ABI (Ankle-Brachial Index) | ABI in the target limb | 1, 6 and 12 months | 
| Toe pressure | Toe pressure in the target limb | 1, 6 and 12 months | 
| Device success rates | Percentage of exact deployment of the device according to the instructions for use as documented with suitable imaging modalities | Through angioplasty completion | 
| Technical success rates | Percentage of successful vascular access, completion of the endovascular procedure and immediate morphological success with less or equal to 50% residual diameter reduction of the treated lesion on completion angiography | Through angioplasty completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical limb ischemia, bellow-the-knee angioplasty, drug-eluting balloon