Clinical trial · Interventional
LEVANT Japan Clinical Trial
A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
NCT01816412CI-TRIAL-00024070completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Femoral Arterial Stenosis | — | UNRESOLVED | — |
| Femoral Artery Occlusion | — | UNRESOLVED | — |
| Occlusion of Popliteal Arteries | — | UNRESOLVED | — |
| Stenosis of Popliteal Arteries | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MD02-LDCB Paclitaxel coated balloon catheter | Device | — | UNRESOLVED |
| Standard Uncoated Balloon Angioplasty Catheter | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LDCB
- description
- Paclitaxel Coated Balloon
- interventionNames
- Device: MD02-LDCB Paclitaxel coated balloon catheter
- type
- ACTIVE_COMPARATOR
- label
- PTA
- description
- Standard Uncoated Balloon Angioplasty Catheter PTA Catheter
- interventionNames
- Procedure: Standard Uncoated Balloon Angioplasty Catheter
Primary outcomes (1)
- measure
- Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Male or non-pregnant female ≥20 years of age; * Rutherford Clinical Category 2-4; * Length ≤15 cm; * ≥70% stenosis * Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk; * A patent inflow artery as confirmed by angiography * At least one patent native outflow artery to the ankle Exclusion Criteria: * Life expectancy of \< 2 years; * History of hemorrhagic stroke within 3 months; * Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure; * History of MI, thrombolysis or angina within 2 weeks of enrollment; * Renal failure or chronic kidney disease * Severe calcification that renders the lesion un-dilatable
References
Publications (2)
- DERIVEDMa GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3. PMID 42573020
- DERIVEDOuriel K, Adelman MA, Rosenfield K, Scheinert D, Brodmann M, Pena C, Geraghty P, Lee A, White R, Clair DG. Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease. JACC Cardiovasc Interv. 2019 Dec 23;12(24):2515-2524. doi: 10.1016/j.jcin.2019.08.025. Epub 2019 Sep 28. PMID 31575518