UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036056 |
|---|---|
| Receipt number | 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 | 2020/06/22 15:04:40 |
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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
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
Yoko.Takizawa@bsci.com
Sponsor or person
Institute
Boston Scientific Japan K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041049
