Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter. All Comers Registry.

Study Overview
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Brief Summary
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A total of up to 250 patients from an all-comers patient population with infrainguinal atherosclerotic disease who are implanted or scheduled for an implant with a Ranger Drug coated balloon. Interim analysis will be carried out for every 50 subjects enrolled.

Official Title
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Ranger DEB All Comers Registry - Treatment of Femoro-popliteal Atherosclerotic Lesions Using the Ranger Paclitaxel Coated Balloon Catheter: An All Comers Registry.

Conditions
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Atherosclerotic Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Patient must be willing to sign a a patient informed consent form. Patient with de novo, restenotic or reoccluded lesions in the infrainguinal .arteries implanted or scheduled for an implant with a Ranger Drug coated balloon. Target vessel reference diameter 2.5 to 8 mm. Exclusion Criteria: Subjects pregnant or planning to become pregnant during the course of the study. Life expectancy of less than 1 year. Known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications. Subject enrolled in another study that has not reached its primary endpoint at the time of enrolment.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALL COMERS<br>Patients implanted or scheduled for an implant with a Ranger Drug coated balloon. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical primary endpoint: Major Adverse Events (MAE) defined as composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 6 months post-index procedure. |  | 6 Months | 
| Performance primary endpoint: Primary patency at 12 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary patency at 6 and 24 months, defined as freedom from > 50% restenosis with no clinically-driven reintervention |  | 6 and 24 Months | 
| MAE at 12 and 24 months |  | 12 and 24 Months | 
| Technical success, defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual stenosis (visual assessment) |  | Intraoperative | 
| Device success, defined as exact deployment of the device according to the IFU (operator assessment) |  | Intraoperative | 
| Procedural success, defined as the combination of technical success and device success |  | Intraoperative | 
| Ankle-Brachial Index (ABI) at 6, 12 and 24 months (and prior to any reintervention) |  | 6, 12 and 24 months | 
| Improvement of at least one Rutherford class at 6, 12 and 24 months (an prior to any reintervention) compared to the pre-procedure Rutherford classification. |  | 6, 12 and 24 months | 
| Target Lesion Revascularization (TLR) and Target Vessel Revascularization (TVR) at 6, 12 and 24 months. |  | 6, 12 and 24 months | 
| Limb salvage, defined as preservation of the treated limb with no need for any amputation at 6, 12 and 24 months. |  | 6, 12 and 24 months | 
| Improvement of pain score at 6, 12 and 24 months compared to the pre-procedure score |  | 6, 12 and 24 months |