Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Not Applicable

Completed

Conditions: Peripheral Arterial Disease

Interventions: Device: EverCross Percutaneous Transluminal Balloon Catheter
Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Registration Number: NCT01858428

Lead Sponsor: Spectranetics Corporation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 300

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bare PTA	EverCross Percutaneous Transluminal Balloon Catheter	The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	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.

Primary Outcome Measures

Name	Time	Method
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization	30 Days and 12 months	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.
Patency at 12 Month Post-procedure	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Mortality Rate	6, 12, 24, 36, 48 and 60 months
Rate of Vascular Access and Bleeding Complications	in-hospital and 1, 6, 12 and 24 months	Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.
Rate of Target Lesion Revascularization	6, 12, 24, 36, 48 and 60 months
Patency Rate and Freedom From Clinically-driven TLR	6, 24 and 36 months	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
Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%	procedure, Day 0	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.
Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure	1, 6, 12, 24, 36, 48 and 60 months	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).
Rate of Clinically-driven Target Lesion Revascularization	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
Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%	procedure, Day 0	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.
Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure	procedure, Day 0	Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.
Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure	procedure, Day 0	Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.
Rate of Target Limb Major Amputation	1, 6, 12, 24, 36, 48 and 60 months
Change in Ankle-brachial Index (ABI) From Pre-procedure	6, 12, 24 and 36 months	Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.

Trial Locations

Locations (44): Northside Hospital
🇺🇸
Atlanta, Georgia, United States
OhioHealth Research Institute
🇺🇸
Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Cardiovascular Research of North Florida
🇺🇸
Gainesville, Florida, United States
Mount Sinai Medical Center
🇺🇸
New York, New York, United States
Mission Hospital
🇺🇸
Asheville, North Carolina, United States
North Ohio Research LTD.
🇺🇸
Elyria, Ohio, United States
University Surgical Associates
🇺🇸
Chattanooga, Tennessee, United States
Texas Health & Research Education Institution
🇺🇸
Dallas, Texas, United States
Sentara Vascular Specialist
🇺🇸
Norfolk, Virginia, United States
Baptist Cardiac and Vascular Institute
🇺🇸
Miami, Florida, United States
University of Texas Health Science Center
🇺🇸
Houston, Texas, United States
Oklahoma Foundation for Cardiovascular Research
🇺🇸
Oklahoma City, Oklahoma, United States
Hanusch Krankenhaus Wien
🇦🇹
Vienna, Austria
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
LKH Univ. - Klinikum Graz
🇦🇹
Graz, Austria
Providence Heart and Vascular Institute
🇺🇸
Portland, Oregon, United States
Sanford Health Vascular Associates
🇺🇸
Sioux Falls, South Dakota, United States
Pinnacle Health Cardiovascular Institute, INC.
🇺🇸
Wormleysburg, Pennsylvania, United States
Mission Cardiovascular Research Institute
🇺🇸
Fremont, California, United States
Yuma Regional Medical Center
🇺🇸
Yuma, Arizona, United States
Good Samaritan Hospital - Los Angeles
🇺🇸
Los Angeles, California, United States
Medical Center of the Rockies
🇺🇸
Loveland, Colorado, United States
Coastal Vascular and Interventional
🇺🇸
Pensacola, Florida, United States
St. Joseph Hospital
🇺🇸
Fort Wayne, Indiana, United States
Deborah Heart and Lung Center
🇺🇸
Browns Mills, New Jersey, United States
Cardiac & Vascular Research Center of Northern Michigan
🇺🇸
Petoskey, Michigan, United States
Metro Health Hospital
🇺🇸
Wyoming, Michigan, United States
Rex Hospital
🇺🇸
Raleigh, North Carolina, United States
Wake Heart Research
🇺🇸
Raleigh, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Jobst Vascular Institute
🇺🇸
Toledo, Ohio, United States
Heritage Valley Health System
🇺🇸
Beaver, Pennsylvania, United States
Providence Cardiology LLC
🇺🇸
Columbia, South Carolina, United States
Premier Surgical Associates
🇺🇸
Knoxville, Tennessee, United States
Wellmont Holston Area Medical Center
🇺🇸
Kingsport, Tennessee, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
El Paso Cardiology Associates
🇺🇸
El Paso, Texas, United States
Jackson Heart Clinic
🇺🇸
Jackson, Mississippi, United States
Advocate Health and Hospitals Corporation
🇺🇸
Oakbrook Terrace, Illinois, United States
CAMC Clinical Trial Center
🇺🇸
Charleston, West Virginia, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Aurora Health Care
🇺🇸
Milwaukee, Wisconsin, United States
Central Iowa Hospital Corporation
🇺🇸
Des Moines, Iowa, United States