UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries
Acronym	Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
Scientific Title	A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal Arteries
Scientific Title:Acronym	Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
Region	Japan

Condition
Condition	Peripheral Arterial Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and effectiveness of the Jetstream Atherectomy System (BSJ009J) for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native SFA and/ or PPA
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Lesion success rate at the index procedure
Key secondary outcomes	- Procedural success rate - Rate of distal emboli requiring additional treatment during the procedure or within 24 hours post-index procedure. - Reduction in lesion stenosis, that is, the difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream - MAE rate at 1 month and 6 months - Clinically-driven TLR and Target Vessel Revascularization (TVR) Rate at each time point - Adverse Event rates at each time point - Distribution of Rutherford Class as compared to baseline at 1 month and 6 months post-index procedure - Rate of Primary and Secondary Sustained Clinical Improvement - Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index as compared to baseline at 1 month and 6 months post-index procedure - Primary Patency and Assisted Primary Patency at 1 month and 6 months

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Jetstream Atherectomy System
Interventions/Control_2
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	- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4. - Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet the following criteria: - Severely calcified lesions with degree of stenosis =>70% by visual angiographic assessment - Vessel diameter =>3.0 mm and <=6.0 mm by visual estimate - Total lesion length (or series of lesions) <=150 mm by visual estimate
Key exclusion criteria	- Target lesion/vessel with in-stent restenosis - History of major amputation in the target limb - Subject has a history of coagulopathy or hypercoagulable bleeding disorder - Subject with untreatable hemorrhagic disease or platelet count <80,000 mm^3 or >600,000 mm^3 as baseline assessment. - History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment - Unstable angina pectoris at the time of the enrollment - Septicemia at the time of enrollment - Presence of other hemodynamically significant outflow lesions in the target limb requiring a planned surgical intervention or endovascular procedure within 30 days after the index procedure - Presence of aneurysm in the target vessel - Acute ischemia and/or acute thrombosis of the SFA/PPA prior to the index procedure - Perforated vessel as evidenced by extravasation of contrast media prior to the index procedure
Target sample size	31

Research contact person
Name of lead principal investigator	1st name Kazushi Middle name Last name URASAWA
Organization	Tokeidai Memorial Hospital
Division name	Cardiovascular Center
Zip code	060-0031
Address	2-3, North-1, East-1, Chuo-Ku Sapporo, Hokkaido, Japan
TEL	011-251-1221
Email	k-urasawa@tokeidaihosp.or.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name TAKIZAWA
Organization	Boston Scientific Japan K.K.
Division name	Clinical Sciences
Zip code	164-0001
Address	4-10-2 Nakano, Nakano-ku, Tokyo, Japan
TEL	03-6853-7500
Homepage URL
Email	Yoko.Takizawa@bsci.com

Sponsor
Institute	Boston Scientific Japan K.K.
Institute
Department

Funding Source
Organization	Boston Scientific Japan K.K.
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	Kokura Memorial Hospital IRB
Address	3-2-1 Asano, Kokura kita-ku, Kitakyushu-city, Fukuoka
Tel	093-511-3248
Email	crc@kokurakinen.or.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT03847233
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW	初回届出年月日: 2016年2月8日; 届出回数: 第2回

Institutions
Institutions	時計台記念病院（北海道）、春日部中央総合病院（埼玉県）、関西労災病院（兵庫県）、小倉記念病院（福岡県）、東京ベイ浦安市川医療センター（千葉県）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 01 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	31
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	2019 Year 02 Month 05 Day
Date of IRB	2019 Year 02 Month 18 Day
Anticipated trial start date	2019 Year 03 Month 19 Day
Last follow-up date	2020 Year 05 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 01 Day
Last modified on	2020 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041049