Clinical trial NCT01870401: Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Official title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Limb Ischemia
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Bard Ltd
First posted: 2013-06-06
Enrollment: 442
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 30 days post index procedure
measure: 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.
timeFrame: 6 months post-index procedure
Secondary outcomes:
measure: Percentage of Lesions Considered Technical Success at Time of Index Procedure
timeFrame: At time of index procedure
measure: Percentage of Procedures With Procedural Success at Time of Index Procedure.
timeFrame: At time of Index Procedure
measure: 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.
timeFrame: 30 days post index procedure
measure: Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.
timeFrame: 30 days, 6 and 12 months post index procedure compared to baseline
measure: Late Lumen Loss at 12 Months Post Index Procedure
timeFrame: 12 months post-index procedure
measure: Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
timeFrame: 30 days, 6 and 12 months post index procedure compared to baseline
measure: Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days and at 6 and 12 months
measure: Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Composite of Freedom From Clinically -Driven Target Lesion Revascularization (TLR) and From 50% DS by Angiography or Duplex Ultrasound at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
timeFrame: 30 days, 6 and 12 months post index procedure compared to baseline
measure: Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
timeFrame: 30 days, and at 6 and 12 months compared to baseline
measure: Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
timeFrame: 30 days, 6 and 12 months post index procedure compared to baseline
measure: Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days and at 6 and 12 months
measure: Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.
timeFrame: 30 days, 6 and 12 months post index procedure
measure: Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure
timeFrame: 30 days, 6 and 12 months post index procedure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University-Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Bradenton
country: United States
facility: Cardiovascular Solutions Institute, LLC
state: Florida
city: Clearwater
country: United States
facility: Morton Plant Mease Health Care, Inc
state: Florida
city: Gainesville
country: United States
facility: Cardiovascular Research of North Florida, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Lakeland
country: United States
facility: Radiology and Imaging Specialists of Lakeland, P.A
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai Medical Center
state: Florida
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: West Des Moines
country: United States
facility: Central Iowa Hospital Corporation
state: Iowa
city: Houma
country: United States
facility: CIS Clinical Research Corporation
state: Louisiana
city: Boston
country: United States
facility: Steward St. Elizabeth Medical Center of Boston
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Wyoming
country: United States
facility: Metro Health-University of Michigan Health Hospital
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic, P.A.
state: Mississippi
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Browns Mills
country: United States
facility: Deborah Heart & Lung Ctr
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, LLC
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Cincinnati
country: United States
facility: Trihealth Heart Institute
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: OhioHealth Corporation
state: Ohio
city: Portland
country: United States
facility: Providence Health & Service - Oregon
state: Oregon
city: Providence
country: United States
facility: The Miriam Hospital - A Lifespan Partner
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: University Surgical Associates, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Cardiology Services, Inc.
state: Tennessee
city: Austin
country: United States
facility: Austin Heart PLLC
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center Health System
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora St. Luke's Vascular Center
state: Wisconsin
city: Graz
country: Austria
facility: Medical University Graz
city: Genk
country: Belgium
facility: ZOL St. Jan
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Arnsberg
country: Germany
facility: Klinik für Kardiologie • Klinikum Arnsberg GmbH
city: Bad Krozingen
country: Germany
facility: Universitaets Herzzentrum Freiburg/Bad Krozingen
city: Heidelberg
country: Germany
facility: Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
city: Immenstadt
country: Germany
facility: Hospital Kempten
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig Medical Centre
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Innere Medizin C
city: Sonneberg
country: Germany
facility: Medinos Kliniken des Landkriess Sonneberg GmbH
city: Tübingen
country: Germany
facility: University of Tubingen, Dept. of Diagnostic and Interventional Radiology
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
city: Minato-ku, Tokyo
country: Japan
facility: The Jikei University Hospital
city: Osaka
country: Japan
facility: Morinomiya Hospital
city: Osaka
country: Japan
facility: Kishiwada Tokushukai Hospital
city: Tokyo
country: Japan
facility: Toho University
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
Study officials:
affiliation: Washington University School of Medicine
name: Patrick Geraghty, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Metro Health Hospital
name: Jihad Mustapha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Graz, Austria
name: Marianne Brodmann, MD
role: PRINCIPAL_INVESTIGATOR
References: