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LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis (LEVANT I)

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ClinicalTrials.gov Identifier: NCT00930813
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
C. R. Bard

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Atherosclerosis
Vascular Disease
Arteriosclerosis
Interventions Device: Lutonix Catheter
Device: Standard uncoated Balloon Angioplasty Catheter
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lutonix DCB Catheter Uncoated PTA Balloon Catheter
Hide Arm/Group Description Lutonix DCB: Paclitaxel Coated Balloon Catheter Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
Period Title: Overall Study
Started 49 52
Completed 41 38
Not Completed 8 14
Reason Not Completed
Death             4             5
Withdrawal by Subject             2             5
Lost to Follow-up             2             4
Arm/Group Title Lutonix Catheter Standard Uncoated Balloon Angioplasty Catheter Total
Hide Arm/Group Description

Paclitaxel coated Balloon Catheter

Lutonix Catheter: Paclitaxel Coated Balloon Catheter

uncoated angioplasty balloon

Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter

Total of all reporting groups
Overall Number of Baseline Participants 49 52 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 52 participants 101 participants
67  (8) 70  (10) 68  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 101 participants
Female
15
  30.6%
22
  42.3%
37
  36.6%
Male
34
  69.4%
30
  57.7%
64
  63.4%
Lesion location  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 101 participants
SFA 45 49 94
Popliteal 4 3 7
Lesion Length  
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 49 participants 52 participants 101 participants
81  (37) 80  (38) 81  (38)
Lesion totally occluded  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 101 participants
Yes 20 22 42
No 29 30 59
Rutherford Class  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 101 participants
2 (Moderate claudication) 11 11 22
3 (Severe claudication) 35 37 72
4 (Ischemia rest pain) 1 2 3
5 (Minor tissue loss) 2 2 4
1.Primary Outcome
Title Angiographic Late Lumen Loss
Hide Description Loss in analysis segment (the treated segment including 10mm distal and proximal) minimal lumen diameter from post-procedure through follow-up angiography at 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.
Arm/Group Title Lutonix DCB Catheter Standard Uncoated PTA Catheter
Hide Arm/Group Description:
Lutonix Paclitaxel Coated Balloon Catheter
Standard off-the-shelf uncoated PTA Catheter
Overall Number of Participants Analyzed 39 35
Mean (Standard Deviation)
Unit of Measure: mm
0.46  (1.13) 1.09  (1.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lutonix DCB Catheter, Standard Uncoated PTA Catheter
Comments The study required 100 subjects to provide 80% power to detect a clinically meaningful difference in late lumen loss of 15% of reference vessel diameter between treatment groups on the basis of a 2-sample Student t test with 2-sided alpha 0.05.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Safety - Device Related Adverse Events
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lutonix DCB Catheter Uncoated PTA Balloon Catheter
Hide Arm/Group Description:
Lutonix DCB: Paclitaxel Coated Balloon Catheter
Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
Overall Number of Participants Analyzed 49 52
Measure Type: Number
Unit of Measure: participants
0 4
3.Secondary Outcome
Title Primary Patency of Treated Segment
Hide Description [Not Specified]
Time Frame 6, 12, 24 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Target Lesion Revascularization
Hide Description [Not Specified]
Time Frame 6, 12, 24 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Target Vessel Revascularization
Hide Description [Not Specified]
Time Frame 6, 12, 24 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Device Success
Hide Description Successful delivery and deployment of the first inserted study device (in overlapping setting a successful delivery and deployment of the first and second study device) at the intended target lesion and successful withdrawal of the study device with attainment of final residual stenosis of less than 30% of the target lesion by quantitative vessel angiography (QVA).
Time Frame at procedure
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Procedural Success
Hide Description Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)
Time Frame at procedure
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Change in Ankle-brachial Index
Hide Description [Not Specified]
Time Frame pre-procedure, 6, 12 and 24 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Change in Walking Impairment Questionnaire (WIQ)
Hide Description [Not Specified]
Time Frame pre-procedure, 6, 12 and 24 months
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Change in Rutherford Grade
Hide Description [Not Specified]
Time Frame pre-procedure,6, 12 and 24 months
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Serum Paclitaxel Levels - in Subsets of Patients
Hide Description [Not Specified]
Time Frame 0, 1, 3 hours and pre-discharge
Outcome Measure Data Not Reported
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lutonix Catheter Standard Uncoated Balloon Angioplasty Catheter
Hide Arm/Group Description

Paclitaxel coated Balloon Catheter

Lutonix Catheter: Paclitaxel Coated Balloon Catheter

uncoated angioplasty balloon

Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter

All-Cause Mortality
Lutonix Catheter Standard Uncoated Balloon Angioplasty Catheter
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lutonix Catheter Standard Uncoated Balloon Angioplasty Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/49 (79.59%)      39/52 (75.00%)    
Blood and lymphatic system disorders     
Anemia   0/49 (0.00%)  0 1/52 (1.92%)  1
Cardiac disorders     
Acute coronary syndrome   1/49 (2.04%)  1 1/52 (1.92%)  1
Angina, stable   3/49 (6.12%)  3 2/52 (3.85%)  3
Arrhythmia - Bradycardia   1/49 (2.04%)  1 0/52 (0.00%)  0
Arrhythmia - Other   1/49 (2.04%)  1 2/52 (3.85%)  2
Arrhytmia - Tachycardia   1/49 (2.04%)  1 2/52 (3.85%)  2
Myocardial infarction   1/49 (2.04%)  1 1/52 (1.92%)  1
Stroke – ischemic   2/49 (4.08%)  2 0/52 (0.00%)  0
TIA   1/49 (2.04%)  1 0/52 (0.00%)  0
Cardiogenic shock   0/49 (0.00%)  0 1/52 (1.92%)  1
Congenital, familial and genetic disorders     
Dementia   0/49 (0.00%)  0 1/52 (1.92%)  1
Ear and labyrinth disorders     
Dizziness / vertigo   0/49 (0.00%)  0 1/52 (1.92%)  1
Endocrine disorders     
Hyperthyroidism   0/49 (0.00%)  0 1/52 (1.92%)  1
Gastrointestinal disorders     
Gastrointestinal bleeding   1/49 (2.04%)  1 1/52 (1.92%)  1
Gastrointestinal: other infectious / inflammatory   1/49 (2.04%)  1 0/52 (0.00%)  0
Nausea   2/49 (4.08%)  2 0/52 (0.00%)  0
Gastritis   0/49 (0.00%)  0 1/52 (1.92%)  1
General disorders     
Abscess   1/49 (2.04%)  1 0/52 (0.00%)  0
Battery depletion of pacemaker   1/49 (2.04%)  1 0/52 (0.00%)  0
Bleeding out of mouth and nose   1/49 (2.04%)  1 0/52 (0.00%)  0
Death (non-cardiac or neurological)   1/49 (2.04%)  1 1/52 (1.92%)  1
Diffuse bleeding on metatarsus   1/49 (2.04%)  1 0/52 (0.00%)  0
Malfunction of the defibrillator   1/49 (2.04%)  1 0/52 (0.00%)  0
Infections and infestations     
Sepsis   1/49 (2.04%)  1 1/52 (1.92%)  1
Arthralgia   0/49 (0.00%)  0 1/52 (1.92%)  1
Local infection   0/49 (0.00%)  0 2/52 (3.85%)  3
Wound lower leg with infection (MRSA) and maggots   0/49 (0.00%)  0 1/52 (1.92%)  1
Injury, poisoning and procedural complications     
Access site complication: pseudo aneurysm   2/49 (4.08%)  2 3/52 (5.77%)  3
Fracture (bone)   1/49 (2.04%)  1 0/52 (0.00%)  0
Groin hernia   1/49 (2.04%)  1 0/52 (0.00%)  0
Patient fell down, pain in the back   1/49 (2.04%)  1 0/52 (0.00%)  0
Patient was injured during fall : bruise left hip   1/49 (2.04%)  1 0/52 (0.00%)  0
Vessel specific complication (not puncture site or target vessel): Embolism   1/49 (2.04%)  1 0/52 (0.00%)  0
Worseness of ulceration on amputation wound   1/49 (2.04%)  1 0/52 (0.00%)  0
Wound dehiscence after CABG   1/49 (2.04%)  1 0/52 (0.00%)  0
Wound infection after amputation of second toe   1/49 (2.04%)  1 0/52 (0.00%)  0
Access site complication: Arterial occlusion puncture site   0/49 (0.00%)  0 2/52 (3.85%)  2
Aggregate change of pacemaker   0/49 (0.00%)  0 1/52 (1.92%)  1
Control coronary angiography   0/49 (0.00%)  0 1/52 (1.92%)  1
Defibrillator control   0/49 (0.00%)  0 1/52 (1.92%)  1
Fall from bed - urinary bladder infection   0/49 (0.00%)  0 1/52 (1.92%)  1
Vessel specific complication (not puncture site or target vessel): Hematoma / bleeding   0/49 (0.00%)  0 1/52 (1.92%)  1
Target lesion - Thrombus - in-lesion   0/49 (0.00%)  0 1/52 (1.92%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Carcinoma   2/49 (4.08%)  2 0/52 (0.00%)  0
Colon carcinoma   0/49 (0.00%)  0 1/52 (1.92%)  1
Psychiatric disorders     
Depression   0/49 (0.00%)  0 1/52 (1.92%)  1
Renal and urinary disorders     
Hematuria   1/49 (2.04%)  1 0/52 (0.00%)  0
Hypertension   1/49 (2.04%)  1 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia   1/49 (2.04%)  1 2/52 (3.85%)  2
Dyspnea   0/49 (0.00%)  0 2/52 (3.85%)  2
Skin and subcutaneous tissue disorders     
Not any healing of ulceration on right foot   1/49 (2.04%)  1 0/52 (0.00%)  0
Persistent wound healing disorder   1/49 (2.04%)  2 0/52 (0.00%)  0
Surgical and medical procedures     
Amputation   1/49 (2.04%)  6 1/52 (1.92%)  1
Vascular disorders     
Target lesion - Restinosis   13/49 (26.53%)  20 17/52 (32.69%)  22
Death (Cardiovascular)   1/49 (2.04%)  1 1/52 (1.92%)  1
Target vessel - Restenosis   2/49 (4.08%)  2 2/52 (3.85%)  3
Vessel specific complication (not puncture site or target vessel): Arterial occlusion   4/49 (8.16%)  4 6/52 (11.54%)  7
Vessel specific complication (not puncture site or target vessel): Arterial thrombosis   1/49 (2.04%)  1 2/52 (3.85%)  3
Vessel specific complication (not puncture site or target vessel): Atherosclerosis   5/49 (10.20%)  6 14/52 (26.92%)  18
Vessel specific complication (not puncture site or target vessel): Restenosis   9/49 (18.37%)  10 7/52 (13.46%)  9
Claudication   0/49 (0.00%)  0 2/52 (3.85%)  2
Target lesion - Occlusion / closure   0/49 (0.00%)  0 3/52 (5.77%)  4
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lutonix Catheter Standard Uncoated Balloon Angioplasty Catheter
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/49 (34.69%)      28/52 (53.85%)    
Injury, poisoning and procedural complications     
Access site complication: pseudo aneurysm   1/49 (2.04%)  1 3/52 (5.77%)  3
Access site complication: Hematoma/bleeding puncture site   4/49 (8.16%)  4 3/52 (5.77%)  3
Target lesion - Dissection   0/49 (0.00%)  0 4/52 (7.69%)  4
Renal and urinary disorders     
Hypertension   0/49 (0.00%)  0 3/52 (5.77%)  3
Vascular disorders     
Claudication   4/49 (8.16%)  4 4/52 (7.69%)  4
Target lesion - Restenosis   7/49 (14.29%)  11 4/52 (7.69%)  4
Vessel specific complication (not puncture site or target vessel): Atherosclerosis   1/49 (2.04%)  1 7/52 (13.46%)  7
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chris Barry
Organization: Lutonix Inc. a subsidiary of C.R. Bard
Phone: 763-445-2352
EMail: LutonixResearch@crbard.com
Layout table for additonal information
Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT00930813     History of Changes
Other Study ID Numbers: CL0012-01
First Submitted: June 30, 2009
First Posted: July 2, 2009
Results First Submitted: August 5, 2014
Results First Posted: December 21, 2015
Last Update Posted: December 21, 2015