Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
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ClinicalTrials.gov Identifier: NCT01870401 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 6, 2013
Last Update Posted
: February 1, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Critical Limb Ischemia | Device: Lutonix DCB Device: Uncoated PTA Catheter | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 442 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | June 3, 2013 |
Estimated Primary Completion Date : | July 12, 2018 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
|
Device: Lutonix DCB
Other Name: LTX DCB
|
Active Comparator: PTA Catheter
Standard Uncoated PTA Catheter
|
Device: Uncoated PTA Catheter
Other Name: PTA
|
- Freedom from BTK MALE+POD [ Time Frame: 30 days ]Composite of all-cause death, above-ankle amputation or major reintervention
- Limb Salvage [ Time Frame: 6 months ]Freedom from the composite of above ankle amputation
- Primary Patency [ Time Frame: 6 months ]Freedom from target vessel occlusion and clinically driven target lesion reintervention
- Wound healing [ Time Frame: 30 days; 6 months, 12 months, 24 months, and 36 months ]Healed or not, if not, improving, stagnant, worsening
- Primary Patency [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]Freedom from occlusion without clinically-driven Target Lesion Revascularization (TLR)
- Hemodynamic outcome [ Time Frame: 30 days and at 6 months, 12 months, 24 months, and 36 months ]change in toe & ankle pressures
- Clinically-driven TLR [ Time Frame: 30 days and at 6, 12, 24, and 36 months ]Revascularization performed on all randomized patients who returned with clinical symptoms, and if the subject has a target lesion diameter stenosis ≥ 50%.
- Limb salvage in surviving subjects [ Time Frame: 30 days and at 6, 12, 24, and 36 months ]No Amputation of target limb

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870401

Principal Investigator: | 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 |
Responsible Party: | C. R. Bard |
ClinicalTrials.gov Identifier: | NCT01870401 History of Changes |
Other Study ID Numbers: |
CL0005-01 |
First Posted: | June 6, 2013 Key Record Dates |
Last Update Posted: | February 1, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Ischemia Pathologic Processes |