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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036056
Receipt No. R000041049
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
Date of disclosure of the study information 2019/03/01
Last modified on 2019/04/02

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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)

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
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 Open public recruiting
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 02 Month 29 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
2019 Year 04 Month 02 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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