Status:
COMPLETED
LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis
Lead Sponsor:
C. R. Bard
Conditions:
Atherosclerosis
Vascular Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.
Detailed Description
The LEVANT I trial will enroll patients presenting with clinical evidence of claudication or critical limb ischemia and an angiographically significant lesion in the femoropopliteal arteries. Patients...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00930813
Start Date
June 1 2009
End Date
December 1 2011
Last Update
December 21 2015
Active Locations (10)
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1
Sint Blasius
Dendermonde, Belgium
2
Herz Zentrum
Bad Krozingen, Germany
3
Jewish Hospital
Berlin, Germany
4
St Katharenen Cardiovascular Center
Frankfurt, Germany