Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
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
1 other identifier
interventional
60
1 country
10
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Jetstream Atherectomy System for the treatment of Japanese patients with symptomatic occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/or proximal popliteal arteries (PPA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedStudy Start
First participant enrolled
May 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2017
CompletedResults Posted
Study results publicly available
September 10, 2018
CompletedJanuary 8, 2019
December 1, 2018
1.1 years
March 24, 2016
June 27, 2018
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Patency Rate
6 months
Other Outcomes (12)
Procedural Success Rate
during procedure
Rate of Distal Emboli Requiring Additional Treatment
during procedure or within 24 hours post-index procedure
Reduction in Lesion Stenosis
during procedure
- +9 more other outcomes
Study Arms (1)
Jetstream Atherectomy System
EXPERIMENTALAdjunctive therapy with Jetstream Atherectomy System for percutaneous intervention
Interventions
A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
Eligibility Criteria
You may qualify if:
- Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2-4
- Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA of which meet all of the following criteria:
- Calcified lesions with degree of stenosis ≥70% or occlusions
- Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course
- Vessel diameter ≥3.0 mm and ≤6.0 mm
- Total lesion length (or series of lesions) ≤150mm
- Target lesion located at least 3 cm above the inferior edge of the femur by visual estimate
- Patent infrapopliteal and popliteal artery
You may not qualify if:
- Target lesion/vessel with in-stent restenosis
- Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to the procedure
- Target lesion/vessel previously treated with any stent placement, atherectomy, laser or other debulking devices prior to the procedure
- Subjects who have undergone surgery or endovascular of the SFA/PPA in the target vessel to treat atherosclerotic disease within 3 months prior to the index procedure
- Use of drug-coated devices, atherectomy, laser or other debulking devices other than the Jetstream System, chronic total occlusion (CTO) devices or cutting balloon, Angioscore or similar devices in the target limb SFA/PPA during the index procedure
- 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 \<80,000mm3 or \>600,000mm3 as baseline assessment.
- Concomitant renal failure with a serum creatinine \>2.0 mg/dL
- Receiving dialysis or immunosuppressant therapy
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Nagoya Kyoritsu Hospital
Nagoya, Aichi-ken, 454-0933, Japan
Kokura Memorial Hospital
Kokura, Fukuoka, 802-8555, Japan
Iwaki Kyouritsu Hospital
Iwaki, Fukushima, 973-8555, Japan
Tokeidai Memorial Hospital
Sapporo, Hokkaido, 060-0031, Japan
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511, Japan
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, 230-8765, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-8522, Japan
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063, Japan
Miyazaki Medical Association Hospital
Miyazaki, 880-0834, Japan
Nagano Red Cross Hospital
Nagano, 380-8582, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Yoko Takizawa/Clinical Project Manager
- Organization
- Boston Scientific Japan K.K.
Study Officials
- PRINCIPAL INVESTIGATOR
Kazushi Urasawa, MD, PhD
Tokeidai Memorial Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2016
First Posted
April 11, 2016
Study Start
May 25, 2016
Primary Completion
June 29, 2017
Study Completion
December 20, 2017
Last Updated
January 8, 2019
Results First Posted
September 10, 2018
Record last verified: 2018-12