UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042695 |
|---|---|
| Receipt number | R000047378 |
| Scientific Title | A Comparative Clinical Trial for Critical Limb Ischemia with Paclitaxel Coating Balloon Catheter (JLL-LEG). |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2020/12/09 09:01:23 |
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Basic information
Public title
A Comparative Clinical Trial for Critical Limb Ischemia with Paclitaxel Coating Balloon Catheter (JLL-LEG).
Acronym
The JLL-LEG Pivotal Trial
Scientific Title
A Comparative Clinical Trial for Critical Limb Ischemia with Paclitaxel Coating Balloon Catheter (JLL-LEG).
Scientific Title:Acronym
The JLL-LEG Pivotal Trial
Region
| Japan |
Condition
Condition
Critical Limb Ischemia
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of JLL-LEG in comparison with conventional percutaneous angioplasty for patients with critical limb ischemia who have stenosis or occlusion below the popliteal arteries.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Treatment success rate of target limb at 6 months post procedure.
Treatment success is defined as the target wounds are healed without target lesion revascularization and unplanned lower limb amputation.
Key secondary outcomes
Efficacy
- Technical success rate
- Initial treatment success rate
- Clinical success rate of target limb [Time Frame: 30 days, 3 and 6 months post procedure]
- Unplanned lower limb amputation of target limb at 6 months post procedure
- Target lesion revascularization at 6 months post procedure
- Patency of target limb at 6 months post procedure
- Time to wound healing of target limb
- Time to achievement of granulation of target wounds
- Wound healing rate of target limb [Time Frame: 30 days, 3 and 6 months post procedure]
- EQ-5D assessment [Time Frame: 30 days, 3 and 6 months post procedure]
Safety
- Mortality rate [Time Frame: 30 days, 3, 6 and 12 months post procedure]
- MACE rate [Time Frame: 30 days, 3, 6 and 12 months post procedure]
- MALE rate [Time Frame: 30 days, 3, 6 and 12 months post procedure]
- Major amputation rate [Time Frame: 30 days, 3, 6 and 12 months post procedure]
- Perioperative vascular complication rate of target limb
- Perioperative puncture site complication rate of target limb
- Adverse event
- Clinical laboratory test (hematological test, biochemical test of blood serum chemistry, blood coagulation/fibrinolysis system test and examination of urine), Vital signs (blood pressure, pulse rate), Objective blood flow assessment (SPP, Echo)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Drug Coating Balloon (JLL-LEG)
Interventions/Control_2
Standard PTA
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Subject is 20 years or older at the time of obtaining consent.
(2) In the case of complex lesions of the femoral and iliac arteries, subject who can perform prior treatment of inflow lesions.
(3) Subject with stenosis or occlusion below the popliteal arteries (Reference vessel diameter is 2 mm or more and 6 mm or less, cumulative lesion length is less than 380 mm).
(4) Subject with critical limb ischemia corresponding to Rutherford categories 5 that meet the following criteria. However, in the past, endovascular treatment has been performed below the popliteal arteries, and recurrent cases with wound healing can be included.
1) SPP value is less than 40 mmHg. However, this does not apply if ischemia can be diagnosed by echo evaluation when it is judged that the SPP value is clinically invalid.
2) Needs conservative treatment for wounds or local treatment such as debridement is planned.
3) If both limbs correspond to Rutherford categories 5, subject is one limb, and can protect the target limb from wounds (hospitalization, decompression, etc.).
(5) Subject is eligible for EVT.
(6) Subject with a prognosis of life of 1 year or more.
(7) Subject who can obtain written informed consent to voluntary prior to participating in this clinical trial.
Key exclusion criteria
(1) Subject who undergoes EVT as a pretreatment for major amputation or who is expected to cannot avoid major amputation even if EVT is performed.
(2) Subject with severe heart failure.
(3) Subject with untreated severe coronary artery disease.
(4) Subject with severe infection.
(5) Subject with ulcers on the heel.
(6) Subject with inflammation extending to the sole of the foot.
(7) Subject with accumulated pus in the wounds.
(8) Subject with taking steroids.
(9) Subject with albumin value less than 2.5 g/dl.
(10) Subject with low ADL (WHO PS score of 4 or more). Except when it is caused by the underlying disease.
(11) Subject with ulcers that are unlikely to becaused by lower limb ischemia, because lower limb blood flow is evaluated to be sufficiently by objective blood flow assessment (angiography, echo, etc.).
(12) Subject with ulcers caused by primary diseases other than arteriosclerosis such as vasculitis.
(13) Subject with major amputation on the contralateral limb.
(14) Subject with Rutherford categories 6 on the contralateral limb.
(15) Subject with pregnant or possibly pregnant and lactating.
(16) Subject with hypersensitivity reaction to aspirin, heparin, clopidogrel or ticlopidine.
(17) Subject with a history of contraindications or allergies to contrast agents. However, subject with a history of allergies are excluded when preoperative administration of steroids can prevent symptoms.
(18) Subject with bleeding tendency or abnormal blood coagulation, who cannot perform emergency blood transfusion, or who is contraindicated for antiplatelet drugs.
(19) Subject with stroke or transient ischemic attack (TIA) within 6 months before preoperative.
(20) Subject with treatment history of abdominal aorta within 1 month before preoperative.
(21) Subject who have paclitaxel-eluting stents placed on the target limbs within 1 year before preoperative.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nakamura |
Organization
Toho University Ohashi Medical Center
Division name
Division of Cardiovascular Medicine
Zip code
153-8515
Address
2-22-36, Ohashi, Meguro-ku, Tokyo, Japan
TEL
03-3468-1251
masato@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Horikawa |
Organization
Japan Lifeline Co., Ltd.
Division name
Regulatory Affairs General Management Business Unit Clinical Affairs Section
Zip code
140-0002
Address
2-2-20, Higashishinagawa, Shinagawa-ku, Tokyo, Japan
TEL
03-6711-5264
Homepage URL
k-horikawa@jll.co.jp
Sponsor or person
Institute
Japan Lifeline Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japan Lifeline Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University Ohashi Medical Center Institutional Review Board
Address
2-22-36, Ohashi, Meguro-ku, Tokyo, Japan
Tel
03-3481-8025
tikencrc@oha.toho-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
初回届出年月日：2014年8月14日 届出回数：第1回
Institutions
Institutions
小倉記念病院（福岡県）、倉敷中央病院（岡山県）、関西労災病院（兵庫県）、新須磨病院（兵庫県）、金沢医科大学病院（石川県）、湘南鎌倉総合病院（神奈川県）、横浜市東部病院（神奈川県）、東邦大学医療センター大橋病院（東京都）、春日部中央総合病院（埼玉県）、時計台記念病院（北海道）、板橋中央総合病院（東京都）、松山赤十字病院（愛媛県）、東京労災病院（東京都）、森之宮病院（大阪府）、杏林大学医学部付属病院（東京都）、船橋市立総合医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
160
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047378
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