Trial Outcomes & Findings for LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis (NCT NCT00930813)
NCT ID: NCT00930813
Last Updated: 2015-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
101 participants
Primary outcome timeframe
6 months
Results posted on
2015-12-21
Participant Flow
Participant milestones
| Measure |
Lutonix DCB Catheter
Lutonix DCB: Paclitaxel Coated Balloon Catheter
|
Uncoated PTA Balloon Catheter
Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
52
|
|
Overall Study
COMPLETED
|
41
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
Reasons for withdrawal
| Measure |
Lutonix DCB Catheter
Lutonix DCB: Paclitaxel Coated Balloon Catheter
|
Uncoated PTA Balloon Catheter
Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
|
|---|---|---|
|
Overall Study
Death
|
4
|
5
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
Baseline characteristics by cohort
| Measure |
Lutonix Catheter
n=49 Participants
Paclitaxel coated Balloon Catheter
Lutonix Catheter: Paclitaxel Coated Balloon Catheter
|
Standard Uncoated Balloon Angioplasty Catheter
n=52 Participants
uncoated angioplasty balloon
Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 8 • n=5 Participants
|
70 years
STANDARD_DEVIATION 10 • n=7 Participants
|
68 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Lesion location
SFA
|
45 participants
n=5 Participants
|
49 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Lesion location
Popliteal
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Lesion Length
|
81 mm
STANDARD_DEVIATION 37 • n=5 Participants
|
80 mm
STANDARD_DEVIATION 38 • n=7 Participants
|
81 mm
STANDARD_DEVIATION 38 • n=5 Participants
|
|
Lesion totally occluded
Yes
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Lesion totally occluded
No
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Rutherford Class
2 (Moderate claudication)
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Rutherford Class
3 (Severe claudication)
|
35 participants
n=5 Participants
|
37 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Rutherford Class
4 (Ischemia rest pain)
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Rutherford Class
5 (Minor tissue loss)
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.
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.
Outcome measures
| Measure |
Lutonix DCB Catheter
n=39 Participants
Lutonix Paclitaxel Coated Balloon Catheter
|
Standard Uncoated PTA Catheter
n=35 Participants
Standard off-the-shelf uncoated PTA Catheter
|
|---|---|---|
|
Angiographic Late Lumen Loss
|
0.46 mm
Standard Deviation 1.13
|
1.09 mm
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 30 daysPopulation: ITT
Outcome measures
| Measure |
Lutonix DCB Catheter
n=49 Participants
Lutonix Paclitaxel Coated Balloon Catheter
|
Standard Uncoated PTA Catheter
n=52 Participants
Standard off-the-shelf uncoated PTA Catheter
|
|---|---|---|
|
Safety - Device Related Adverse Events
|
0 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 6, 12, 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6, 12, 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6, 12, 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at procedureSuccessful 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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at procedureCompletion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-procedure, 6, 12 and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-procedure, 6, 12 and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-procedure,6, 12 and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0, 1, 3 hours and pre-dischargeOutcome measures
Outcome data not reported
Adverse Events
Lutonix Catheter
Serious events: 39 serious events
Other events: 17 other events
Deaths: 0 deaths
Standard Uncoated Balloon Angioplasty Catheter
Serious events: 39 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lutonix Catheter
n=49 participants at risk
Paclitaxel coated Balloon Catheter
Lutonix Catheter: Paclitaxel Coated Balloon Catheter
|
Standard Uncoated Balloon Angioplasty Catheter
n=52 participants at risk
uncoated angioplasty balloon
Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter
|
|---|---|---|
|
Vascular disorders
Target lesion - Restinosis
|
26.5%
13/49 • Number of events 20 • 24 months
|
32.7%
17/52 • Number of events 22 • 24 months
|
|
General disorders
Abscess
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Access site complication: pseudo aneurysm
|
4.1%
2/49 • Number of events 2 • 24 months
|
5.8%
3/52 • Number of events 3 • 24 months
|
|
Cardiac disorders
Acute coronary syndrome
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Amputation
|
2.0%
1/49 • Number of events 6 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Cardiac disorders
Angina, stable
|
6.1%
3/49 • Number of events 3 • 24 months
|
3.8%
2/52 • Number of events 3 • 24 months
|
|
Cardiac disorders
Arrhythmia - Bradycardia
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Cardiac disorders
Arrhythmia - Other
|
2.0%
1/49 • Number of events 1 • 24 months
|
3.8%
2/52 • Number of events 2 • 24 months
|
|
Cardiac disorders
Arrhytmia - Tachycardia
|
2.0%
1/49 • Number of events 1 • 24 months
|
3.8%
2/52 • Number of events 2 • 24 months
|
|
General disorders
Battery depletion of pacemaker
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
General disorders
Bleeding out of mouth and nose
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma
|
4.1%
2/49 • Number of events 2 • 24 months
|
0.00%
0/52 • 24 months
|
|
Vascular disorders
Death (Cardiovascular)
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
General disorders
Death (non-cardiac or neurological)
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
General disorders
Diffuse bleeding on metatarsus
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Fracture (bone)
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal: other infectious / inflammatory
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Groin hernia
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Renal and urinary disorders
Hypertension
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
General disorders
Malfunction of the defibrillator
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49 • Number of events 2 • 24 months
|
0.00%
0/52 • 24 months
|
|
Skin and subcutaneous tissue disorders
Not any healing of ulceration on right foot
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Patient fell down, pain in the back
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Patient was injured during fall : bruise left hip
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Skin and subcutaneous tissue disorders
Persistent wound healing disorder
|
2.0%
1/49 • Number of events 2 • 24 months
|
0.00%
0/52 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.0%
1/49 • Number of events 1 • 24 months
|
3.8%
2/52 • Number of events 2 • 24 months
|
|
Infections and infestations
Sepsis
|
2.0%
1/49 • Number of events 1 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Cardiac disorders
Stroke - ischemic
|
4.1%
2/49 • Number of events 2 • 24 months
|
0.00%
0/52 • 24 months
|
|
Vascular disorders
Target vessel - Restenosis
|
4.1%
2/49 • Number of events 2 • 24 months
|
3.8%
2/52 • Number of events 3 • 24 months
|
|
Cardiac disorders
TIA
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Vascular disorders
Vessel specific complication (not puncture site or target vessel): Arterial occlusion
|
8.2%
4/49 • Number of events 4 • 24 months
|
11.5%
6/52 • Number of events 7 • 24 months
|
|
Vascular disorders
Vessel specific complication (not puncture site or target vessel): Arterial thrombosis
|
2.0%
1/49 • Number of events 1 • 24 months
|
3.8%
2/52 • Number of events 3 • 24 months
|
|
Vascular disorders
Vessel specific complication (not puncture site or target vessel): Atherosclerosis
|
10.2%
5/49 • Number of events 6 • 24 months
|
26.9%
14/52 • Number of events 18 • 24 months
|
|
Injury, poisoning and procedural complications
Vessel specific complication (not puncture site or target vessel): Embolism
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Vascular disorders
Vessel specific complication (not puncture site or target vessel): Restenosis
|
18.4%
9/49 • Number of events 10 • 24 months
|
13.5%
7/52 • Number of events 9 • 24 months
|
|
Injury, poisoning and procedural complications
Worseness of ulceration on amputation wound
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence after CABG
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Wound infection after amputation of second toe
|
2.0%
1/49 • Number of events 1 • 24 months
|
0.00%
0/52 • 24 months
|
|
Injury, poisoning and procedural complications
Access site complication: Arterial occlusion puncture site
|
0.00%
0/49 • 24 months
|
3.8%
2/52 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Aggregate change of pacemaker
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Infections and infestations
Arthralgia
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Vascular disorders
Claudication
|
0.00%
0/49 • 24 months
|
3.8%
2/52 • Number of events 2 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon carcinoma
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Control coronary angiography
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Defibrillator control
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Congenital, familial and genetic disorders
Dementia
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Ear and labyrinth disorders
Dizziness / vertigo
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/49 • 24 months
|
3.8%
2/52 • Number of events 2 • 24 months
|
|
Injury, poisoning and procedural complications
Fall from bed - urinary bladder infection
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Infections and infestations
Local infection
|
0.00%
0/49 • 24 months
|
3.8%
2/52 • Number of events 3 • 24 months
|
|
Vascular disorders
Target lesion - Occlusion / closure
|
0.00%
0/49 • 24 months
|
5.8%
3/52 • Number of events 4 • 24 months
|
|
Injury, poisoning and procedural complications
Vessel specific complication (not puncture site or target vessel): Hematoma / bleeding
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Infections and infestations
Wound lower leg with infection (MRSA) and maggots
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
|
Injury, poisoning and procedural complications
Target lesion - Thrombus - in-lesion
|
0.00%
0/49 • 24 months
|
1.9%
1/52 • Number of events 1 • 24 months
|
Other adverse events
| Measure |
Lutonix Catheter
n=49 participants at risk
Paclitaxel coated Balloon Catheter
Lutonix Catheter: Paclitaxel Coated Balloon Catheter
|
Standard Uncoated Balloon Angioplasty Catheter
n=52 participants at risk
uncoated angioplasty balloon
Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter
|
|---|---|---|
|
Injury, poisoning and procedural complications
Access site complication: pseudo aneurysm
|
2.0%
1/49 • Number of events 1 • 24 months
|
5.8%
3/52 • Number of events 3 • 24 months
|
|
Injury, poisoning and procedural complications
Access site complication: Hematoma/bleeding puncture site
|
8.2%
4/49 • Number of events 4 • 24 months
|
5.8%
3/52 • Number of events 3 • 24 months
|
|
Vascular disorders
Claudication
|
8.2%
4/49 • Number of events 4 • 24 months
|
7.7%
4/52 • Number of events 4 • 24 months
|
|
Renal and urinary disorders
Hypertension
|
0.00%
0/49 • 24 months
|
5.8%
3/52 • Number of events 3 • 24 months
|
|
Injury, poisoning and procedural complications
Target lesion - Dissection
|
0.00%
0/49 • 24 months
|
7.7%
4/52 • Number of events 4 • 24 months
|
|
Vascular disorders
Target lesion - Restenosis
|
14.3%
7/49 • Number of events 11 • 24 months
|
7.7%
4/52 • Number of events 4 • 24 months
|
|
Vascular disorders
Vessel specific complication (not puncture site or target vessel): Atherosclerosis
|
2.0%
1/49 • Number of events 1 • 24 months
|
13.5%
7/52 • Number of events 7 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60