Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Study Overview
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Brief Summary
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This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.

Detailed Description
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The ILLUMENATE Pivotal study is a prospective, randomized, multi-center, single-blind study which will include up to 360 subjects in approximately forty-five (45) sites across the United States to evaluate the CVI Paclitaxel-coated PTA Catheter compared to the bare percutaneous transluminal angioplasty balloon catheter (bare balloon catheter) for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.

Official Title
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ILLUMENATE Pivotal: ProspectIve, Randomized, SingLe-Blind, U.S. MuLti-Center Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
* Device: EverCross Percutaneous Transluminal Balloon Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery. Exclusion Criteria: Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bare PTA<br>The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA). | Device: EverCross Percutaneous Transluminal Balloon Catheter<br>* The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).<br>|
| Experimental: Drug-Coated PTA<br>The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. | Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter<br>* The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patency at 12 Month Post-procedure | Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization. | 12 months | 
| Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization | Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure. | 30 Days and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure | Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR). | 1, 6, 12, 24, 36, 48 and 60 months | 
| Rate of Vascular Access and Bleeding Complications | Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months. | in-hospital and 1, 6, 12 and 24 months | 
| Rate of Clinically-driven Target Lesion Revascularization |  | 6, 12, 24, 36, 48 and 60 months | 
| Rate of Target Lesion Revascularization |  | 6, 12, 24, 36, 48 and 60 months | 
| Rate of Target Limb Major Amputation |  | 1, 6, 12, 24, 36, 48 and 60 months | 
| Mortality Rate |  | 6, 12, 24, 36, 48 and 60 months | 
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment |  | 1, 6, 12, 24, 36, 48 and 60 months | 
| Patency Rate and Freedom From Clinically-driven TLR | Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months | 6, 24 and 36 months | 
| Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion. | procedure, Day 0 | 
| Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% | Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion. | procedure, Day 0 | 
| Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure | Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure. | procedure, Day 0 | 
| Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure | Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure. | procedure, Day 0 | 
| Change in Ankle-brachial Index (ABI) From Pre-procedure | Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period. | 6, 12, 24 and 36 months |