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

Primary Purpose

Critical Limb Ischemia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Lutonix DCB
Uncoated PTA Catheter
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University-Yale New Haven Hospital
  • MedStar Washington Hospital Center
  • Cardiovascular Solutions Institute, LLC
  • Morton Plant Mease Health Care, Inc
  • Cardiovascular Research of North Florida, LLC
  • University of Florida
  • Radiology and Imaging Specialists of Lakeland, P.A
  • Mt. Sinai Medical Center
  • Prairie Education and Research Cooperative
  • Central Iowa Hospital Corporation
  • CIS Clinical Research Corporation
  • Steward St. Elizabeth Medical Center of Boston
  • Beth Israel Deaconess Medical Center
  • Metro Health-University of Michigan Health Hospital
  • Jackson Heart Clinic, P.A.
  • Barnes Jewish Hospital
  • Deborah Heart & Lung Ctr
  • Holy Name Medical Center
  • New Mexico Heart Institute, LLC
  • Mount Sinai School of Medicine
  • NC Heart & Vascular Research
  • Trihealth Heart Institute
  • Cleveland Clinic Foundation
  • OhioHealth Corporation
  • Providence Health & Service - Oregon
  • The Miriam Hospital - A Lifespan Partner
  • Medical University of South Carolina
  • University Surgical Associates, LLC
  • Wellmont Cardiology Services, Inc.
  • Austin Heart PLLC
  • Sentara Medical Group
  • Charleston Area Medical Center Health System
  • Aurora St. Luke's Vascular Center
  • Medical University Graz
  • ZOL St. Jan
  • University Health Network
  • Klinik für Kardiologie • Klinikum Arnsberg GmbH
  • Universitaets Herzzentrum Freiburg/Bad Krozingen
  • Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
  • Hospital Kempten
  • Universitaetsklinikum Leipzig Medical Centre
  • Universitätsklinikum Münster, Innere Medizin C
  • Medinos Kliniken des Landkriess Sonneberg GmbH
  • University of Tubingen, Dept. of Diagnostic and Interventional Radiology
  • Maria Cecilia Hospital
  • Kasukabe Chuo General Hospital
  • The Jikei University Hospital
  • Morinomiya Hospital
  • Kishiwada Tokushukai Hospital
  • Toho University
  • Kantonsspital Luzern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lutonix DCB

PTA Catheter

Arm Description

Lutonix Paclitaxel Drug Coated Balloon

Standard Uncoated PTA Catheter

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Late Lumen Loss at 12 Months Post Index Procedure
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.
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
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.
Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
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.
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.
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.
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.

Full Information

First Posted
May 7, 2013
Last Updated
February 3, 2022
Sponsor
C. R. Bard
Collaborators
Bard Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01870401
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2013 (Actual)
Primary Completion Date
May 17, 2018 (Actual)
Study Completion Date
June 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
Collaborators
Bard Ltd

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lutonix DCB
Arm Type
Experimental
Arm Description
Lutonix Paclitaxel Drug Coated Balloon
Arm Title
PTA Catheter
Arm Type
Active Comparator
Arm Description
Standard Uncoated PTA Catheter
Intervention Type
Device
Intervention Name(s)
Lutonix DCB
Other Intervention Name(s)
LTX DCB
Intervention Type
Device
Intervention Name(s)
Uncoated PTA Catheter
Other Intervention Name(s)
PTA
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 days post index procedure
Title
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.
Description
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.
Time Frame
6 months post-index procedure
Secondary Outcome Measure Information:
Title
Percentage of Lesions Considered Technical Success at Time of Index Procedure
Description
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.
Time Frame
At time of index procedure
Title
Percentage of Procedures With Procedural Success at Time of Index Procedure.
Description
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.
Time Frame
At time of Index Procedure
Title
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.
Time Frame
30 days post index procedure
Title
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure compared to baseline
Title
Late Lumen Loss at 12 Months Post Index Procedure
Time Frame
12 months post-index procedure
Title
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.
Description
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure compared to baseline
Title
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.
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure
Description
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.
Time Frame
30 days and at 6 and 12 months
Title
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure compared to baseline
Title
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
Description
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.
Time Frame
30 days, and at 6 and 12 months compared to baseline
Title
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure compared to baseline
Title
Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
Time Frame
30 days, 6 and 12 months post index procedure
Title
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.
Description
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure
Description
Limb salvage defined as no amputation of target limb.
Time Frame
30 days and at 6 and 12 months
Title
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.
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.
Description
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.
Time Frame
30 days, 6 and 12 months post index procedure
Title
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
Description
Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
Time Frame
30 days, 6 and 12 months post index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Geraghty, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jihad Mustapha, MD
Organizational Affiliation
Metro Health Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marianne Brodmann, MD
Organizational Affiliation
Medical University Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University-Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Cardiovascular Solutions Institute, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Morton Plant Mease Health Care, Inc
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Cardiovascular Research of North Florida, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Radiology and Imaging Specialists of Lakeland, P.A
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Mt. Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Central Iowa Hospital Corporation
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
CIS Clinical Research Corporation
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Steward St. Elizabeth Medical Center of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Metro Health-University of Michigan Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Jackson Heart Clinic, P.A.
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Deborah Heart & Lung Ctr
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
New Mexico Heart Institute, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NC Heart & Vascular Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Trihealth Heart Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OhioHealth Corporation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214-3907
Country
United States
Facility Name
Providence Health & Service - Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
The Miriam Hospital - A Lifespan Partner
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
University Surgical Associates, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Wellmont Cardiology Services, Inc.
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Austin Heart PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Sentara Medical Group
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Charleston Area Medical Center Health System
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Aurora St. Luke's Vascular Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical University Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
ZOL St. Jan
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Klinik für Kardiologie • Klinikum Arnsberg GmbH
City
Arnsberg
ZIP/Postal Code
59759
Country
Germany
Facility Name
Universitaets Herzzentrum Freiburg/Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Hospital Kempten
City
Immenstadt
ZIP/Postal Code
87509
Country
Germany
Facility Name
Universitaetsklinikum Leipzig Medical Centre
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Münster, Innere Medizin C
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Medinos Kliniken des Landkriess Sonneberg GmbH
City
Sonneberg
ZIP/Postal Code
96515
Country
Germany
Facility Name
University of Tubingen, Dept. of Diagnostic and Interventional Radiology
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Maria Cecilia Hospital
City
Cotignola
Country
Italy
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
ZIP/Postal Code
344-0063
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-ku, Tokyo
ZIP/Postal Code
105-0003
Country
Japan
Facility Name
Morinomiya Hospital
City
Osaka
ZIP/Postal Code
536-0025
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Osaka
ZIP/Postal Code
596-8522
Country
Japan
Facility Name
Toho University
City
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
Kantonsspital Luzern
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland

12. IPD Sharing Statement

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

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