Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

NCT01870401 | Completed Results DMC FDA Device

• 1 other identifier: CL0005-01
• Study Type: interventional
• Target: 442
• Locations: 8 countries
• Sites: 51

Brief Summary

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure.

  The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.

  30 days post index procedure

• Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure.

  The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb.

  6 months post-index procedure

Secondary Outcomes (25)

• Percentage of Lesions Considered Technical Success at Time of Index Procedure

  At time of index procedure

• Percentage of Procedures With Procedural Success at Time of Index Procedure.

  At time of Index Procedure

• Comparison of the Below the Knee (BTK) Major Adverse Limb Event (MALE) and Perioperative Death (POD) Rate to a Performance Goal at 30 Days Post Index Procedure.

  30 days post index procedure

• Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.

  30 days, 6 and 12 months post index procedure compared to baseline

• Late Lumen Loss at 12 Months Post Index Procedure

  12 months post-index procedure

Study Arms (2)

Lutonix DCB

EXPERIMENTAL

Lutonix Paclitaxel Drug Coated Balloon

Device: Lutonix DCB

PTA Catheter

ACTIVE COMPARATOR

Standard Uncoated PTA Catheter

Device: Uncoated PTA Catheter

Interventions

Lutonix DCB DEVICE

Also known as: LTX DCB

Lutonix DCB

Uncoated PTA Catheter DEVICE

Also known as: PTA

PTA Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 3, 4 \& 5;
• Life expectancy ≥ 1 year;
• Significant stenosis (≥70%)
• A patent inflow artery;
• Target vessel(s) diameter between 2 and 4 mm;
• Target vessel(s) reconstitute(s) at or above the ankle

You may not qualify if:

• Pregnant or planning on becoming pregnant;
• History of stroke within 3 months;
• History of MI, thrombolysis or angina within 30 days of enrollment;
• Planned major amputation (of either leg)
• Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating;
• GFR ≤ 30 ml/min per 1.73m2;
• Acute limb ischemia;
• In-stent restenosis of target lesion

Sponsors & Collaborators

• C. R. Bard: lead
• Bard Ltd: collaborator

Study Sites (51)

Yale University-Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Cardiovascular Solutions Institute, LLC

Bradenton, Florida, 34208, United States

Location

Morton Plant Mease Health Care, Inc

Clearwater, Florida, 33756, United States

Location

Cardiovascular Research of North Florida, LLC

Gainesville, Florida, 32605, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Radiology and Imaging Specialists of Lakeland, P.A

Lakeland, Florida, 33805, United States

Location

Mt. Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Central Iowa Hospital Corporation

West Des Moines, Iowa, 50266, United States

Location

CIS Clinical Research Corporation

Houma, Louisiana, 70360, United States

Location

Steward St. Elizabeth Medical Center of Boston

Boston, Massachusetts, 02135, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Metro Health-University of Michigan Health Hospital

Wyoming, Michigan, 49519, United States

Location

Jackson Heart Clinic, P.A.

Jackson, Mississippi, 39216, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Deborah Heart & Lung Ctr

Browns Mills, New Jersey, 08015, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

New Mexico Heart Institute, LLC

Albuquerque, New Mexico, 87102, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

NC Heart & Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Trihealth Heart Institute

Cincinnati, Ohio, 45220, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OhioHealth Corporation

Columbus, Ohio, 43214-3907, United States

Location

Providence Health & Service - Oregon

Portland, Oregon, 97225, United States

Location

The Miriam Hospital - A Lifespan Partner

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University Surgical Associates, LLC

Chattanooga, Tennessee, 37403, United States

Location

Wellmont Cardiology Services, Inc.

Kingsport, Tennessee, 37660, United States

Location

Austin Heart PLLC

Austin, Texas, 78756, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Charleston Area Medical Center Health System

Charleston, West Virginia, 25304, United States

Location

Aurora St. Luke's Vascular Center

Milwaukee, Wisconsin, 53215, United States

Location

Medical University Graz

Graz, A-8036, Austria

Location

ZOL St. Jan

Genk, 3600, Belgium

Location

University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

Klinik für Kardiologie • Klinikum Arnsberg GmbH

Arnsberg, 59759, Germany

Location

Universitaets Herzzentrum Freiburg/Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)

Heidelberg, 69120, Germany

Location

Hospital Kempten

Immenstadt im Allgäu, 87509, Germany

Location

Universitaetsklinikum Leipzig Medical Centre

Leipzig, 04103, Germany

Location

Universitätsklinikum Münster, Innere Medizin C

Münster, 48149, Germany

Location

Medinos Kliniken des Landkriess Sonneberg GmbH

Sonneberg, 96515, Germany

Location

University of Tubingen, Dept. of Diagnostic and Interventional Radiology

Tübingen, 72076, Germany

Location

Maria Cecilia Hospital

Cotignola, Italy

Location

Kasukabe Chuo General Hospital

Kasukabe, 344-0063, Japan

Location

The Jikei University Hospital

Minato-ku, Tokyo, 105-0003, Japan

Location

Morinomiya Hospital

Osaka, 536-0025, Japan

Location

Kishiwada Tokushukai Hospital

Osaka, 596-8522, Japan

Location

Toho University

Tokyo, 153-8515, Japan

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Results Point of Contact

• Title: Lisa Erickson
• Organization: Becton Dickinson

Lisa.Erickson@bd.com

763-463-2897

Study Officials

• Patrick Geraghty, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jihad Mustapha, MD

  Metro Health Hospital

  PRINCIPAL INVESTIGATOR

• Marianne Brodmann, MD

  Medical University Graz, Austria

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: June 6, 2013
• Study Start: June 3, 2013
• Primary Completion: May 17, 2018
• Study Completion: June 22, 2021
• Last Updated: February 9, 2022
• Results First Posted: August 12, 2020

Record last verified: 2022-02

Locations

AU (1); CA (1); IT (1); US (33); BE (1); DE (8); CH (1); JP (5)