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Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

NCT ID: NCT01858428

Last Updated: 2020-08-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-18

Study Completion Date

2018-03-19

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.

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STELLAREX: ILLUMENATE Global and In-Stent Restenosis (ISR)

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bare PTA

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Group Type ACTIVE_COMPARATOR

EverCross Percutaneous Transluminal Balloon Catheter

Intervention Type DEVICE

The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).

Drug-Coated PTA

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.

Group Type EXPERIMENTAL

Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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).

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spectranetics Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prakash Krishnan, MD

Role: PRINCIPAL_INVESTIGATOR

Mt. Sinai Medical Center

Sean Lyden, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Yuma Regional Medical Center

Yuma, Arizona, United States

Site Status

Mission Cardiovascular Research Institute

Fremont, California, United States

Site Status

Good Samaritan Hospital - Los Angeles

Los Angeles, California, United States

Site Status

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Cardiovascular Research of North Florida

Gainesville, Florida, United States

Site Status

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Site Status

Coastal Vascular and Interventional

Pensacola, Florida, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Advocate Health and Hospitals Corporation

Oakbrook Terrace, Illinois, United States

Site Status

St. Joseph Hospital

Fort Wayne, Indiana, United States

Site Status

Central Iowa Hospital Corporation

Des Moines, Iowa, United States

Site Status

Cardiac & Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Site Status

Metro Health Hospital

Wyoming, Michigan, United States

Site Status

Jackson Heart Clinic

Jackson, Mississippi, United States

Site Status

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Site Status

Mount Sinai Medical Center

New York, New York, United States

Site Status

Mission Hospital

Asheville, North Carolina, United States

Site Status

Rex Hospital

Raleigh, North Carolina, United States

Site Status

Wake Heart Research

Raleigh, North Carolina, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

OhioHealth Research Institute

Columbus, Ohio, United States

Site Status

North Ohio Research LTD.

Elyria, Ohio, United States

Site Status

Jobst Vascular Institute

Toledo, Ohio, United States

Site Status

Oklahoma Foundation for Cardiovascular Research

Oklahoma City, Oklahoma, United States

Site Status

Providence Heart and Vascular Institute

Portland, Oregon, United States

Site Status

Heritage Valley Health System

Beaver, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Pinnacle Health Cardiovascular Institute, INC.

Wormleysburg, Pennsylvania, United States

Site Status

Providence Cardiology LLC

Columbia, South Carolina, United States

Site Status

Sanford Health Vascular Associates

Sioux Falls, South Dakota, United States

Site Status

University Surgical Associates

Chattanooga, Tennessee, United States

Site Status

Wellmont Holston Area Medical Center

Kingsport, Tennessee, United States

Site Status

Premier Surgical Associates

Knoxville, Tennessee, United States

Site Status

Texas Health & Research Education Institution

Dallas, Texas, United States

Site Status

El Paso Cardiology Associates

El Paso, Texas, United States

Site Status

University of Texas Health Science Center

Houston, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Sentara Vascular Specialist

Norfolk, Virginia, United States

Site Status

CAMC Clinical Trial Center

Charleston, West Virginia, United States

Site Status

Aurora Health Care

Milwaukee, Wisconsin, United States

Site Status

LKH Univ. - Klinikum Graz

Graz, , Austria

Site Status

Hanusch Krankenhaus Wien

Vienna, , Austria

Site Status

Countries

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United States Austria

References

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Krishnan P, Faries P, Niazi K, Sachar R, Jain A, Brodmann M, Werner M, Holden A, Tarricone A, Tarra T, Lyden S. Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial. Am J Cardiol. 2024 Sep 15;227:83-90. doi: 10.1016/j.amjcard.2024.06.027. Epub 2024 Jul 15.

Reference Type DERIVED
PMID: 39019203 (View on PubMed)

Lyden SP, Brodmann M, Parikh SA, Krishnan P, Schroeder H, Werner M, Holden A, Ouriel K, Tarra T, Gray WA. Four-year patient-level pooled mortality analysis of the ILLUMENATE US Pivotal and EU randomized controlled trials. J Vasc Surg. 2022 Feb;75(2):600-607. doi: 10.1016/j.jvs.2021.07.244. Epub 2021 Sep 8.

Reference Type DERIVED
PMID: 34506898 (View on PubMed)

Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.

Reference Type DERIVED
PMID: 31567024 (View on PubMed)

Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017 Sep 19;136(12):1102-1113. doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20.

Reference Type DERIVED
PMID: 28729250 (View on PubMed)

Other Identifiers

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TP-1397

Identifier Type: -

Identifier Source: org_study_id

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