Critical Limb IschemiaNCT01870401
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
A study testing Lutonix DCB and Uncoated PTA Catheter in people with Critical Limb Ischemia, run by C. R. Bard at 51 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Lutonix DCB and Uncoated PTA Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 51 sitesin 8 countries
- Study dates
- 3 Jun 2013to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
51 sites in 8 countries.
51 sites in 8 countries
United States33 sites
New Mexico Heart Institute, LLC
Albuquerque, New Mexico, 87102
Austin Heart PLLC
Austin, Texas, 78756
Steward St. Elizabeth Medical Center of Boston
Boston, Massachusetts, 02135
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cardiovascular Solutions Institute, LLC
Bradenton, Florida, 34208
Deborah Heart & Lung Ctr
Browns Mills, New Jersey, 08015
Medical University of South Carolina
Charleston, South Carolina, 29425
Charleston Area Medical Center Health System
Charleston, West Virginia, 25304
University Surgical Associates, LLC
Chattanooga, Tennessee, 37403
Trihealth Heart Institute
Cincinnati, Ohio, 45220
Morton Plant Mease Health Care, Inc
Clearwater, Florida, 33756
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
OhioHealth Corporation
Columbus, Ohio, 43214-3907
Cardiovascular Research of North Florida, LLC
Gainesville, Florida, 32605
University of Florida
Gainesville, Florida, 32611
CIS Clinical Research Corporation
Houma, Louisiana, 70360
Jackson Heart Clinic, P.A.
Jackson, Mississippi, 39216
Wellmont Cardiology Services, Inc.
Kingsport, Tennessee, 37660
Radiology and Imaging Specialists of Lakeland, P.A
Lakeland, Florida, 33805
Mt. Sinai Medical Center
Miami Beach, Florida, 33140
Aurora St. Luke's Vascular Center
Milwaukee, Wisconsin, 53215
Yale University-Yale New Haven Hospital
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
Sentara Medical Group
Norfolk, Virginia, 23507
Providence Health & Service - Oregon
Portland, Oregon, 97225
The Miriam Hospital - A Lifespan Partner
Providence, Rhode Island, 02906
NC Heart & Vascular Research
Raleigh, North Carolina, 27607
Prairie Education and Research Cooperative
Springfield, Illinois, 62701
Barnes Jewish Hospital
St Louis, Missouri, 63110
Holy Name Medical Center
Teaneck, New Jersey, 07666
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Central Iowa Hospital Corporation
West Des Moines, Iowa, 50266
Metro Health-University of Michigan Health Hospital
Wyoming, Michigan, 49519
Germany8 sites
Klinik für Kardiologie • Klinikum Arnsberg GmbH
Arnsberg, 59759
Universitaets Herzzentrum Freiburg/Bad Krozingen
Bad Krozingen, 79189
Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
Heidelberg, 69120
Hospital Kempten
Immenstadt im Allgäu, 87509
Universitaetsklinikum Leipzig Medical Centre
Leipzig, 04103
Universitätsklinikum Münster, Innere Medizin C
Münster, 48149
Medinos Kliniken des Landkriess Sonneberg GmbH
Sonneberg, 96515
University of Tubingen, Dept. of Diagnostic and Interventional Radiology
Tübingen, 72076
Japan5 sites
Kasukabe Chuo General Hospital
Kasukabe, 344-0063
The Jikei University Hospital
Minato-ku, Tokyo, 105-0003
Morinomiya Hospital
Osaka, 536-0025
Kishiwada Tokushukai Hospital
Osaka, 596-8522
Toho University
Tokyo, 153-8515
About this study
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)
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
- Being tested
- Lutonix DCB, Uncoated PTA Catheter
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutonix DCBDevice
Also called LTX DCB
Uncoated PTA CatheterDevice
Also called PTA
| Study group | Role | What they receive |
|---|---|---|
| Lutonix DCB | Experimental | Lutonix Paclitaxel Drug Coated Balloon Receives: Device: Lutonix DCB |
| PTA Catheter | Active comparator | Standard Uncoated PTA Catheter Receives: Device: Uncoated PTA Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months post-index procedure
Secondary outcomes (25)
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.
Measured: At time of index procedure
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.
Measured: 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.
Measured: 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.
Measured: 30 days, 6 and 12 months post index procedure compared to baseline
Late Lumen Loss at 12 Months Post Index Procedure
Measured: 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.
Measured: 30 days, 6 and 12 months post index procedure
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
Measured: 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.
Measured: 30 days, 6 and 12 months post index procedure
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.
Measured: 30 days, 6 and 12 months post index procedure compared to baseline
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.
Measured: 30 days, 6 and 12 months post index procedure
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.
Measured: 30 days and at 6 and 12 months
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.
Measured: 30 days, 6 and 12 months post index procedure
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.
Measured: 30 days, 6 and 12 months post index procedure
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.
Measured: 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.
Measured: 30 days, 6 and 12 months post index procedure compared to baseline
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.
Measured: 30 days, and at 6 and 12 months compared to baseline
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.
Measured: 30 days, 6 and 12 months post index procedure compared to baseline
Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
Measured: 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.
Measured: 30 days, 6 and 12 months post index procedure
Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Measured: 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.
Measured: 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.
Measured: 30 days and at 6 and 12 months
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.
Measured: 30 days, 6 and 12 months post index procedure
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.
Measured: 30 days, 6 and 12 months post index procedure
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.
Measured: 30 days, 6 and 12 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study start3 Jun 2013
- Primary completion17 May 2018
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bard Ltd
- Responsible party
- Sponsor
- Investigators
- Patrick Geraghty, MD, Principal investigator, Washington University School of MedicineJihad Mustapha, MD, Principal investigator, Metro Health HospitalMarianne Brodmann, MD, Principal investigator, Medical University Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870401
- Sponsor's protocol ID
- CL0005-01
- Status last verified
- Feb 2022
- First submitted
- 7 May 2013
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01870401
- Acronym / sponsor ID
- CL0005-01
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Bard Ltd
- Study start
- 3 Jun 2013 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutonix DCB | Experimental | Device: Lutonix DCBLutonix Paclitaxel Drug Coated Balloon |
| PTA Catheter | Active comparator | Device: Uncoated PTA CatheterStandard Uncoated PTA Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutonix DCBAlso: LTX DCB | Device | Lutonix DCB |
| Uncoated PTA CatheterAlso: PTA | Device | PTA Catheter |
Primary outcome
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.
Time frame: 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.
Time frame: 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.
25 secondary outcomes
Percentage of Lesions Considered Technical Success at Time of Index Procedure
Time frame: At time of index procedure
Percentage of Procedures With Procedural Success at Time of Index Procedure.
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 6 and 12 months post index procedure compared to baseline
Late Lumen Loss at 12 Months Post Index Procedure
Time frame: 12 months post-index procedure
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure
Time frame: 30 days, 6 and 12 months post index procedure
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
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.
Time frame: 30 days, 6 and 12 months post index procedure
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
Time frame: 30 days, 6 and 12 months post index procedure compared to baseline
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.
Time frame: 30 days, 6 and 12 months post index procedure
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure
Time frame: 30 days and at 6 and 12 months
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure
Time frame: 30 days, 6 and 12 months post index procedure
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure
Time frame: 30 days, 6 and 12 months post index procedure
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
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
Time frame: 30 days, 6 and 12 months post index procedure compared to baseline
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
Time frame: 30 days, and at 6 and 12 months compared to baseline
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
Time frame: 30 days, 6 and 12 months post index procedure compared to baseline
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
Cumulative Number of 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
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
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
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure
Time frame: 30 days and at 6 and 12 months
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.
Time frame: 30 days, 6 and 12 months post index procedure
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.
Time frame: 30 days, 6 and 12 months post index procedure
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
Time frame: 30 days, 6 and 12 months post index procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Geraghty, MD principal investigator
Washington University School of Medicine
Jihad Mustapha, MD principal investigator
Metro Health Hospital
Marianne Brodmann, MD principal investigator
Medical University Graz, Austria
51 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutonix DCB and Uncoated PTA Catheter in people with Critical Limb Ischemia, run by C. R. Bard at 51 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Germany, Japan, Austria, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 30 days post index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.