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

Critical Limb Ischemia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870401
• Other study ID #: CL0005-01
• Status: Completed
• Phase: N/A
• Start date: June 3, 2013
• Est. completion date: June 22, 2021

Study information

• Verified date: February 2022
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: June 22, 2021
• Est. primary completion date: May 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

Device:
• Lutonix DCB

• Uncoated PTA Catheter

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Belgium	ZOL St. Jan	Genk
Canada	University Health Network	Toronto	Ontario
Germany	Klinik für Kardiologie • Klinikum Arnsberg GmbH	Arnsberg
Germany	Universitaets Herzzentrum Freiburg/Bad Krozingen	Bad Krozingen
Germany	Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)	Heidelberg
Germany	Hospital Kempten	Immenstadt
Germany	Universitaetsklinikum Leipzig Medical Centre	Leipzig
Germany	Universitätsklinikum Münster, Innere Medizin C	Münster
Germany	Medinos Kliniken des Landkriess Sonneberg GmbH	Sonneberg
Germany	University of Tubingen, Dept. of Diagnostic and Interventional Radiology	Tübingen
Italy	Maria Cecilia Hospital	Cotignola
Japan	Kasukabe Chuo General Hospital	Kasukabe
Japan	The Jikei University Hospital	Minato-ku, Tokyo
Japan	Kishiwada Tokushukai Hospital	Osaka
Japan	Morinomiya Hospital	Osaka
Japan	Toho University	Tokyo
Switzerland	Kantonsspital Luzern	Luzern
United States	New Mexico Heart Institute, LLC	Albuquerque	New Mexico
United States	Austin Heart PLLC	Austin	Texas
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Steward St. Elizabeth Medical Center of Boston	Boston	Massachusetts
United States	Cardiovascular Solutions Institute, LLC	Bradenton	Florida
United States	Deborah Heart & Lung Ctr	Browns Mills	New Jersey
United States	Charleston Area Medical Center Health System	Charleston	West Virginia
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Surgical Associates, LLC	Chattanooga	Tennessee
United States	Trihealth Heart Institute	Cincinnati	Ohio
United States	Morton Plant Mease Health Care, Inc	Clearwater	Florida
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	OhioHealth Corporation	Columbus	Ohio
United States	Cardiovascular Research of North Florida, LLC	Gainesville	Florida
United States	University of Florida	Gainesville	Florida
United States	CIS Clinical Research Corporation	Houma	Louisiana
United States	Jackson Heart Clinic, P.A.	Jackson	Mississippi
United States	Wellmont Cardiology Services, Inc.	Kingsport	Tennessee
United States	Radiology and Imaging Specialists of Lakeland, P.A	Lakeland	Florida
United States	Mt. Sinai Medical Center	Miami Beach	Florida
United States	Aurora St. Luke's Vascular Center	Milwaukee	Wisconsin
United States	Yale University-Yale New Haven Hospital	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	New York
United States	Sentara Medical Group	Norfolk	Virginia
United States	Providence Health & Service - Oregon	Portland	Oregon
United States	The Miriam Hospital - A Lifespan Partner	Providence	Rhode Island
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	Barnes Jewish Hospital	Saint Louis	Missouri
United States	Prairie Education and Research Cooperative	Springfield	Illinois
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Central Iowa Hospital Corporation	West Des Moines	Iowa
United States	Metro Health-University of Michigan Health Hospital	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
C. R. Bard	Bard Ltd

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Germany,  Italy,  Japan,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Lesions Considered Technical Success at Time of Index Procedure	Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation = 30% was reported.	At time of index procedure
Secondary	Percentage of Procedures With Procedural Success at Time of Index Procedure.	A success is determined if there is restoration of at least 1 infrapopliteal artery with residual stenosis = 30% (or = 50% depending upon the version of the protocol) and inline outflow to the foot, irrespective of device success, and without a major adverse event during the index procedure.	At time of Index Procedure
Secondary	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
Secondary	Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.	Mean change in EuroQol (EQ-5D) scores at 30 days, 6, and 12 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Secondary	Late Lumen Loss at 12 Months Post Index Procedure		12 months post-index procedure
Secondary	Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. The number of wounds analyzed at 6 and 12 months post-index procedure includes wounds that may have appeared (new wounds) since the previous time period reporting.	30 days, 6 and 12 months post index procedure
Secondary	Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.		30 days, 6 and 12 months post index procedure
Secondary	Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.	The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 36 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Secondary	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.	The composite endpoint of freedom from above ankle amputation (CEC-adjudicated), unhealed wound (presence of wound vs. no wound), ischemic rest pain (Rutherford category 4 or higher), target vessel occlusion (based on DUS and/or angiograph), and clinically-driven TVR (CEC-adjudicated).; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure	Primary patency is defined as the absence of both total occlusion (100% diameter stenosis) in all of the target lesions in a flow pathway as well as a clinically-driven Target Lesion Revascularization (TLR).; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days and at 6 and 12 months
Secondary	Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure	Primary patency with exclusion of early mechanical recoil of the target flow pathway is defined as the absence of both total occlusion (100% diameter stenosis) of the target lesions and clinically-driven TLR events > 30 days.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure	The secondary patency of the target lesion is defined as the absence of total occlusion (100% diameter stenosis) of the target lesions based on angiography (if performed) or ultrasound as analyzed by the angiographic Core Lab.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	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.		30 days, 6 and 12 months post index procedure
Secondary	Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline	Mean change from baseline values. The Toe Brachial Index (TBI) is defined as a ratio of toe to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Secondary	Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline	Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, and at 6 and 12 months compared to baseline
Secondary	Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.	The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days 6 and 12 months, compared to baseline assessment scores.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Secondary	Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure		30 days, 6 and 12 months post index procedure
Secondary	Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.		30 days, 6 and 12 months post index procedure
Secondary	Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.		30 days, 6 and 12 months post index procedure
Secondary	Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure	Limb salvage defined as no amputation of target limb.	30 days and at 6 and 12 months
Secondary	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.	Defined as amputation that was below the ankle, including digit amputation. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.	The overall burden of BTK reinterventions was defined as the total number of BTK index-limb re-interventions and major amputations for each time point.; Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Secondary	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	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure