Status:
COMPLETED
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Lead Sponsor:
C. R. Bard
Collaborating Sponsors:
Bard Ltd
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
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
- 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
- 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
Key Trial Info
Start Date :
June 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2021
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT01870401
Start Date
June 3 2013
End Date
June 22 2021
Last Update
February 9 2022
Active Locations (51)
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1
Yale University-Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
2
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
Cardiovascular Solutions Institute, LLC
Bradenton, Florida, United States, 34208
4
Morton Plant Mease Health Care, Inc
Clearwater, Florida, United States, 33756