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Trial record 1 of 3 for:
LUTONIX BTK
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
This study is currently recruiting participants.
Verified August 2017 by C. R. Bard
Sponsor:
C. R. Bard
Collaborator:
Bard Ltd
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01870401
First received: May 7, 2013
Last updated: August 31, 2017
Last verified: August 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Critical Limb Ischemia | Device: Lutonix DCB Device: Uncoated PTA Catheter |
| Study Type: | Interventional |
| Study Design: | 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) |
Resource links provided by NLM:
Further study details as provided by C. R. Bard:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 1000 |
| Study Start Date: | May 2013 |
| Estimated Study Completion Date: | June 2020 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01870401
Show 63 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01870401
Contacts
| Contact: Kimberly Kupcho | kimberly.kupcho@crbard.com |
Show 63 Study Locations
Sponsors and Collaborators
C. R. Bard
Bard Ltd
Investigators
| 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 |
More Information
| Responsible Party: | C. R. Bard |
| ClinicalTrials.gov Identifier: | NCT01870401 History of Changes |
| Other Study ID Numbers: |
CL0005-01 |
| Study First Received: | May 7, 2013 |
| Last Updated: | August 31, 2017 |
Additional relevant MeSH terms:
|
Ischemia Pathologic Processes |
ClinicalTrials.gov processed this record on September 21, 2017