N/A N=442 Randomized Single-blind Treatment

Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

Critical Limb Ischemia

Bottom Line

View on ClinicalTrials.gov: NCT01870401 ↗

Enrolled (actual)

442

Serious AEs

82.8%

Results posted

Aug 2020

Primary outcome: Primary: 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. — 284; 154 Participants — p=<0.025

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lutonix DCB (Device); Uncoated PTA Catheter (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: C. R. Bard
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	284; 154	<0.025 sig
PRIMARY 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.	201; 88	0.0222 sig
SECONDARY Percentage of Lesions Considered Technical Success at Time of Index Procedure	61.3; 58.3	—
SECONDARY Percentage of Procedures With Procedural Success at Time of Index Procedure.	84.0; 81.4	—
SECONDARY 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.	—	—
SECONDARY Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.	1.10; 0.53; 0.07; 0.05; 0.09; 0.12	—
SECONDARY Late Lumen Loss at 12 Months Post Index Procedure	—	—
SECONDARY Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure	49; 24; 61; 45; 42; 17	—
SECONDARY Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.	90; 37; 24; 16; 16; 8	—
SECONDARY Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.	94; 46; 5; 12; 1; 0	—
SECONDARY Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.	161; 83; 100; 59; 2; 2	—
SECONDARY 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.	98; 49; 93; 45; 71; 53	—
SECONDARY Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure	97.4; 94.8; 85.3; 72.2; 58.1; 60.0	—
SECONDARY Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure	100; 100; 88.0; 73.8; 61.7; 63.0	—
SECONDARY Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure	284; 146; 217; 103; 144; 91	—
SECONDARY 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.	—	—
SECONDARY Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline	0.20; 0.28; 0.15; 0.17; 0.12; 0.18	—
SECONDARY Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline	0.23; 0.28; 0.16; 0.17; 0.11; 0.18	—
SECONDARY Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.	0.3; 1.1; 2.9; 3.6; 2.7; 2.3	—
SECONDARY Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure	—	—
SECONDARY Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.	5; 6; 36; 36; 101; 53	—
SECONDARY Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.	—	—
SECONDARY Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.	5; 6; 37; 38; 105; 57	—
SECONDARY Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure	100; 100; 98.9; 98.0; 97.4; 98.0	—
SECONDARY 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.	95.8; 95.5; 88.6; 88.2; 86.3; 83.1	—
SECONDARY Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.	27; 22; 112; 88; 235; 124	—
SECONDARY 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	93.4; 90.3; 78.9; 69.6; 56.8; 58.0	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01870401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.