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)

C. R. Bard51 sites in 7 countries442 target enrollmentJune 3, 2013

ConditionsCritical Limb Ischemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Limb Ischemia
Sponsor: C. R. Bard
Enrollment: 442
Locations: 51
Primary Endpoint: 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.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2013

End Date

June 22, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Percentage of Procedures With Procedural Success at Time of Index Procedure.(At time of Index Procedure)
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.(30 days, 6 and 12 months post index procedure compared to baseline)
Late Lumen Loss at 12 Months Post Index Procedure(12 months post-index procedure)
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.(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(30 days and at 6 and 12 months)
Percentage of Lesions Considered Technical Success at Time of Index Procedure(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.(30 days post index procedure)
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure(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.(30 days, 6 and 12 months post index procedure compared to baseline)
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure(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.(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(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(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.(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.(30 days, 6 and 12 months post index procedure)
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.(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(30 days, 6 and 12 months post index procedure)
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline(30 days, and at 6 and 12 months compared to baseline)
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.(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.(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.(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(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.(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.(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(30 days, 6 and 12 months post index procedure)