LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the P... | NCT00930813

Label	Type	Description	Intervention Names
Lutonix Catheter	Experimental	Paclitaxel coated Balloon Catheter	Device: Lutonix Catheter
Standard uncoated Balloon Angioplasty Catheter	Active Comparator	uncoated angioplasty balloon	Device: Standard uncoated Balloon Angioplasty Catheter

Name	Type	Description	Arm Group Labels	Other Names
Lutonix Catheter	Device	Paclitaxel Coated Balloon Catheter	Lutonix Catheter

Measure	Description	Time Frame
Angiographic Late Lumen Loss	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.	6 months

Measure	Description	Time Frame
Safety - Device Related Adverse Events		30 days
Primary Patency of Treated Segment		6, 12, 24 months
Target Lesion Revascularization

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical Criteria

Male or non-pregnant female ≥18 years of age.
Rutherford Clinical Category 2-5
Patient is willing to provide informed consent and comply with the required follow up visits, testing schedule, and medication regimen Angiographic Criteria
A single de novo or restenotic atherosclerotic lesion >70% in the SFA or popliteal artery that is ≥4 cm and ≤15 cm in total length.
Reference vessel diameter ≥4 mm and ≤ 6mm
Successful wire crossing of lesion
A patent inflow artery free from significant lesion (>50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of inflow artery lesions)

Exclusion Criteria:

Pregnant or planning on becoming pregnant in < 2yrs
Live expectancy of <2 years
Patient actively participating in another investigational device or drug study
History of hemorrhagic stroke within 3 months
Previous or planned surgical or interventional procedure within 30 days of index procedure
Chronic renal insufficiency with creatinine >2.5 mg/L
Prior surgery of the target lesion
Inability to take required study medications
Anticipated use of IIb/IIIa inhibitor prior to randomization
Lesion length is <4 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured
Known inadequate distal outflow
Significant inflow disease
Acute or sub-acute thrombus in target vessel
Severe lesion calcification
Acute vessel occlusion or sudden symptom onset
Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon, etc.)
Prior participation in the current study

Facility	Status	City	State	ZIP	Country	Contacts
Sint Blasius		Dendermonde			Belgium
Herz Zentrum

PubMed Identifier	Type	Citation	Retractions
18272892	Background	Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, Claussen CD, Oldenburg A, Scheller B, Speck U. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008 Feb 14;358(7):689-99. doi: 10.1056/NEJMoa0706356.
18779447	Background	Werk M, Langner S, Reinkensmeier B, Boettcher HF, Tepe G, Dietz U, Hosten N, Hamm B, Speck U, Ricke J. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation. 2008 Sep 23;118(13):1358-65. doi: 10.1161/CIRCULATIONAHA.107.735985. Epub 2008 Sep 8.

ID	Title	Description
FG000	Lutonix DCB Catheter	Lutonix DCB: Paclitaxel Coated Balloon Catheter
FG001	Uncoated PTA Balloon Catheter	Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter

ID	Title	Description
BG000	Lutonix Catheter	Paclitaxel coated Balloon Catheter Lutonix Catheter: Paclitaxel Coated Balloon Catheter
BG001	Standard Uncoated Balloon Angioplasty Catheter	uncoated angioplasty balloon Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00049 BG00152 BG002101

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Angiographic Late Lumen Loss

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.

Intent-to-treat among completers, including all patients with valid angiographic imaging analyzable by the core lab.

Posted

Mean

Standard Deviation

6 months

ID	Title	Description
OG000	Lutonix DCB Catheter	Lutonix Paclitaxel Coated Balloon Catheter
OG001	Standard Uncoated PTA Catheter	Standard off-the-shelf uncoated PTA Catheter

Units	Counts
Participants	OG00039 OG00135

Title

Denominators

Categories

Title	Measurements
	OG0000.46± 1.13 OG0011.09± 1.07

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	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.	t-test, 2 sided		0.016						2-Sided							No	Superiority or Other

Secondary

Safety - Device Related Adverse Events

ITT

Posted

Number

participants

30 days

ID	Title	Description
OG000	Lutonix DCB Catheter	Lutonix DCB: Paclitaxel Coated Balloon Catheter
OG001	Uncoated PTA Balloon Catheter	Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter

Units	Counts
Participants	OG00049

Secondary

Primary Patency of Treated Segment

Not Posted

6, 12, 24 months

Secondary

Target Lesion Revascularization

Not Posted

6, 12, 24 months

Secondary

Target Vessel Revascularization

Not Posted

6, 12, 24 months

Secondary

Device Success

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).

Not Posted

at procedure

Secondary

Procedural Success

Completion of the procedure with less than 30% residual stenosis by QVA of the target lesion (after prolonged dilation and stenting, if necessary)

Not Posted

at procedure

Secondary

Change in Ankle-brachial Index

Not Posted

pre-procedure, 6, 12 and 24 months

Secondary

Change in Walking Impairment Questionnaire (WIQ)

Not Posted

pre-procedure, 6, 12 and 24 months

Secondary

Change in Rutherford Grade

Not Posted

pre-procedure,6, 12 and 24 months

Secondary

Serum Paclitaxel Levels - in Subsets of Patients

Not Posted

0, 1, 3 hours and pre-discharge

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Target lesion - Restinosis	Vascular disorders	Systematic Assessment	EG00020 events13 affected49 at risk EG00122 events17 affected52 at risk
Abscess	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Access site complication: pseudo aneurysm	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected49 at risk EG0013 events3 affected52 at risk
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Amputation	Surgical and medical procedures	Systematic Assessment	EG0006 events1 affected49 at risk EG0011 events1 affected52 at risk
Angina, stable	Cardiac disorders	Systematic Assessment	EG0003 events3 affected49 at risk EG0013 events2 affected52 at risk
Arrhythmia - Bradycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Arrhythmia - Other	Cardiac disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected52 at risk
Arrhytmia - Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected52 at risk
Battery depletion of pacemaker	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Bleeding out of mouth and nose	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected52 at risk
Death (Cardiovascular)	Vascular disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Death (non-cardiac or neurological)	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Diffuse bleeding on metatarsus	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Fracture (bone)	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Gastrointestinal bleeding	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Gastrointestinal: other infectious / inflammatory	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Groin hernia	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Hypertension	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Malfunction of the defibrillator	General disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected52 at risk
Not any healing of ulceration on right foot	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Patient fell down, pain in the back	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Patient was injured during fall : bruise left hip	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Persistent wound healing disorder	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events1 affected49 at risk EG0010 events0 affected52 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected52 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected52 at risk
Stroke - ischemic	Cardiac disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0010 events0 affected52 at risk
Target vessel - Restenosis	Vascular disorders	Systematic Assessment	EG0002 events2 affected49 at risk EG0013 events2 affected52 at risk
TIA	Cardiac disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Vessel specific complication (not puncture site or target vessel): Arterial occlusion	Vascular disorders	Systematic Assessment	EG0004 events4 affected49 at risk EG0017 events6 affected52 at risk
Vessel specific complication (not puncture site or target vessel): Arterial thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected49 at risk EG0013 events2 affected52 at risk
Vessel specific complication (not puncture site or target vessel): Atherosclerosis	Vascular disorders	Systematic Assessment	EG0006 events5 affected49 at risk EG00118 events14 affected52 at risk
Vessel specific complication (not puncture site or target vessel): Embolism	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Vessel specific complication (not puncture site or target vessel): Restenosis	Vascular disorders	Systematic Assessment	EG00010 events9 affected49 at risk EG0019 events7 affected52 at risk
Worseness of ulceration on amputation wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Wound dehiscence after CABG	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Wound infection after amputation of second toe	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected52 at risk
Access site complication: Arterial occlusion puncture site	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected52 at risk
Aggregate change of pacemaker	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Arthralgia	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Claudication	Vascular disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected52 at risk
Colon carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Control coronary angiography	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Defibrillator control	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Dementia	Congenital, familial and genetic disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Dizziness / vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0012 events2 affected52 at risk
Fall from bed - urinary bladder infection	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Local infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0013 events2 affected52 at risk
Target lesion - Occlusion / closure	Vascular disorders	Systematic Assessment	EG0000 events0 affected49 at risk EG0014 events3 affected52 at risk
Vessel specific complication (not puncture site or target vessel): Hematoma / bleeding	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Wound lower leg with infection (MRSA) and maggots	Infections and infestations	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk
Target lesion - Thrombus - in-lesion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected52 at risk

ID	Term
D050197	Atherosclerosis
D014652	Vascular Diseases
D001161	Arteriosclerosis

ID	Term
D001157	Arterial Occlusive Diseases
D002318	Cardiovascular Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lutonix Catheter	Paclitaxel coated Balloon Catheter Lutonix Catheter: Paclitaxel Coated Balloon Catheter			39	49	17	49
EG001	Standard Uncoated Balloon Angioplasty Catheter	uncoated angioplasty balloon Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter			39	52	28	52