Femoral Arterial StenosisPhase 2NCT01816412
LEVANT Japan Clinical Trial
A Phase 2 study testing MD02-LDCB Paclitaxel coated balloon catheter and Standard Uncoated Balloon Angioplasty Catheter in people with Femoral Arterial Stenosis and Stenosis of Popliteal Arteries, run by C. R. Bard at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion
- What is being tested?
- MD02-LDCB Paclitaxel coated balloon catheter and Standard Uncoated Balloon Angioplasty Catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
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.
Read the detailed description
The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.
- Conditions
- Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion, Occlusion of Popliteal Arteries
- Being tested
- MD02-LDCB Paclitaxel coated balloon catheter, Standard Uncoated Balloon Angioplasty Catheter
- Keywords
- Arms, Experimental, Drug Coated Angioplasty Balloon, Active Comparator, Standard angioplasty balloon
- Medical subject headings
- Rhabdomyosarcoma, Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD02-LDCB Paclitaxel coated balloon catheterDevice
Standard Uncoated Balloon Angioplasty CatheterProcedure or surgery
Also called PTA Catheter
| Study group | Role | What they receive |
|---|---|---|
| LDCB | Experimental | Paclitaxel Coated Balloon Receives: Device: MD02-LDCB Paclitaxel coated balloon catheter |
| PTA | Active comparator | Standard Uncoated Balloon Angioplasty Catheter PTA Catheter Receives: Procedure: Standard Uncoated Balloon Angioplasty Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Primary Patency
Measured: 6 months
Secondary outcomes (2)
Safety
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.
Measured: 1, 3, 6, 12 and 24 months
Efficacy
Primary Patency of the target lesion at 6 months. Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).
Measured: 1, 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femoral Arterial StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medicon, Inc.
- Responsible party
- Sponsor
- Investigators
- Hiroyoshi Yokoi, Principal investigator, Kokura Memorial Hospital Cardiovascular Internal MedicineOsamu lida, Principal investigator, Kansai Rosai Hospital Cardiovascular Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816412
- Sponsor's protocol ID
- MD02-LDCB
- Status last verified
- Sep 2016
- First submitted
- 19 Mar 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ma 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.
PubMed 42573020Ouriel 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.
PubMed 31575518
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
- ClinicalTrials.gov ID
- NCT01816412
- Acronym / sponsor ID
- MD02-LDCB
- Conditions
- Femoral Arterial Stenosis, Stenosis of Popliteal Arteries, Femoral Artery Occlusion, Occlusion of Popliteal Arteries
- Keywords
- Arms, Experimental, Drug Coated Angioplasty Balloon, Active Comparator, Standard angioplasty balloon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Collaborators
- Medicon, Inc.
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LDCB | Experimental | Device: MD02-LDCB Paclitaxel coated balloon catheterPaclitaxel Coated Balloon |
| PTA | Active comparator | Procedure: Standard Uncoated Balloon Angioplasty CatheterStandard Uncoated Balloon Angioplasty Catheter PTA Catheter |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD02-LDCB Paclitaxel coated balloon catheter | Device | LDCB |
| Standard Uncoated Balloon Angioplasty CatheterAlso: PTA Catheter | Procedure or surgery | PTA |
Primary outcome
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.
Time frame: 6 months
Primary Patency
2 secondary outcomes
Safety
Time frame: 1, 3, 6, 12 and 24 months
Efficacy
Time frame: 1, 3, 6, 12 and 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
- Derived from this study: PubMed 42573020Ma 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.
- Derived from this study: PubMed 31575518Ouriel 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.
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an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
Femoral Artery Stenosis, Angioplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiroyoshi Yokoi principal investigator
Kokura Memorial Hospital Cardiovascular Internal Medicine
Osamu lida principal investigator
Kansai Rosai Hospital Cardiovascular Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MD02-LDCB Paclitaxel coated balloon catheter and Standard Uncoated Balloon Angioplasty Catheter in people with Femoral Arterial Stenosis and Stenosis of Popliteal Arteries, run by C. R. Bard at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816412, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.