FREERIDE STUDY, Freeway Paclitaxel Coated Balloon Catheter to Treat Peripheral Artery Disease

Study Overview
=================
Brief Summary
-----------------
The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.

Official Title
-----------------
Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study

Conditions
-----------------
Peripheral Artery Disease

Intervention / Treatment
-----------------
* Device: Percutaneous transluminal angioplasty with uncoated balloon
* Device: Percutaneous transluminal angioplasty with Paclitaxel balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female (> 18 years of age) with symptomatic ischemia, requiring treatment of SFA or PI segment ( 2-5 of Rutherford classification) Single and/or multiple de novo occluded, stenotic or reoccluded, restenotic lesion(s) of > 70% , ≤ 15 cm in total length and vessel diameter ≥ 4mm and ≤ 7mm (by visual estimation). Patient provides a signed informed consent and complies with the follow up visits Successful wire crossing of lesion At least one patent (less than 50% stenosis) tibioperoneal run-off vessel Exclusion Criteria: Gastrointestinal bleeding or coagulopathy contraindicating use of anti-platelet therapy Known intolerance contraindications to study medications and contrast agents, non-controllable with medication. Patient actively participating in another device or drug study History of hemorrhagic stroke within 3 months Previous or planned surgical or intervention procedure within 30 days of index procedure Significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured Acute or sub-acute thrombus in target vessel Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon) Patients with in-stent restenosis or prior surgery of the target lesion Patients with abdominal aortic, iliaca or popliteal aneurysm (AAA) with ≥ 4cm diameter

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Uncoated PTA balloon catheter<br>Dilatation with uncoated PTA balloon catheter | Device: Percutaneous transluminal angioplasty with uncoated balloon<br> <br> |
| Active Comparator: Freeway Paclitaxel balloon catheter<br>Dilatation with Freeway Paclitaxel (3 µg/mm2) coated balloon catheter | Device: Percutaneous transluminal angioplasty with Paclitaxel balloon<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of clinically driven target lesion revascularization |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | Baseline | 
| Clinical success |  | Baseline | 
| Procedural success |  | Baseline | 
| Ankle Brachial index improvement |  | 6, 12, 24 months | 
| Change in Rutherford classification |  | 6, 12, 24 months | 
| Walking improvement |  | 6, 12 ,24 months | 
| Rate of minor and major complications |  | 6,12, 24 months | 
| Rate of target lesion revascularization |  | 12, 24 months | 
| Late lumen loss |  | 6 months | 
| Patency rate |  | 6, 12, 24 months |