Peripheral Arterial DiseaseNCT02733653
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)
A study testing Jetstream Atherectomy System in people with Peripheral Arterial Disease, run by Boston Scientific Corporation at 10 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Jetstream Atherectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesJapan
- Study dates
- 25 May 2016to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511
Iwaki Kyouritsu Hospital
Iwaki, Fukushima, 973-8555
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-8522
Kokura Memorial Hospital
Kokura, Fukuoka, 802-8555
Miyazaki Medical Association Hospital
Miyazaki, 880-0834
Nagano Red Cross Hospital
Nagano, 380-8582
Nagoya Kyoritsu Hospital
Nagoya, Aichi-ken, 454-0933
Tokeidai Memorial Hospital
Sapporo, Hokkaido, 060-0031
Saiseikai Yokohama-City Eastern Hospital
Yokohama, Kanagawa, 230-8765
About this study
Official 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
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).
Read the detailed description
A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Jetstream Atherectomy System
- Keywords
- Superficial Femoral Artery, Proximal Popliteal Artery, Endovascular therapy, Atherectomy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jetstream Atherectomy SystemDevice
A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
| Study group | Role | What they receive |
|---|---|---|
| Jetstream Atherectomy System | Experimental | Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention Receives: Device: Jetstream Atherectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start25 May 2016
- Primary completion29 Jun 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazushi Urasawa, MD, PhD, Principal investigator, Tokeidai Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733653
- Sponsor's protocol ID
- S6051
- Status last verified
- Dec 2018
- First submitted
- 24 Mar 2016
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02733653
- Acronym / sponsor ID
- S6051
- Conditions
- Peripheral Arterial Disease
- Keywords
- Superficial Femoral Artery, Proximal Popliteal Artery, Endovascular therapy, Atherectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 May 2016 (actual)
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Posted 10 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A prospective, multicenter, single-arm trial evaluating the safety and efficacy of the Jetstream Atherectomy System in the treatment of symptomatic occlusive atherosclerotic lesions ≤150 mm in length located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Jetstream Atherectomy System | Experimental | Device: Jetstream Atherectomy SystemAdjunctive therapy with Jetstream Atherectomy System for percutaneous intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Patent infrapopliteal and popliteal artery
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jetstream Atherectomy SystemA rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA | Device | Jetstream Atherectomy System |
Primary outcome
Primary Patency Rate
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazushi Urasawa, MD, PhD principal investigator
Tokeidai Memorial Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jetstream Atherectomy System in people with Peripheral Arterial Disease, run by Boston Scientific Corporation at 10 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.