UMIN-CTR Clinical Trial

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
Email	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
Email	k-horikawa@jll.co.jp

Sponsor
Institute	Japan Lifeline Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047378