Peripheral Arterial DiseaseNCT03847233
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
A study testing Jetstream Atherectomy System in people with Peripheral Arterial Disease, run by Boston Scientific Corporation at 5 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
- 31 participants
- Where
- 5 sitesJapan
- Study dates
- 19 Mar 2019to 20 May 2020
- 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 the following criteria:
- Severely calcified lesions with degree of stenosis ≥70%
- Vessel diameter ≥3.0 mm and ≤6.0 mm
- Total lesion length (or series of lesions) ≤150 mm
Who cannot join
- 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 <80,000mm3 or >600,000mm3 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
Show all 11Show fewer
- 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
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo, 660-8511
Kasukabe Chuo General Hospital
Kasukabe, Saitama, 344-0063
Kokura Memorial Hospital
Kokura, Fukuoka, 802-8555
Tokeidai Memorial Hospital
Sapporo, Hokkaido, 060-0031
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, 279-0001
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 | Not described Receives: Device: Jetstream Atherectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Lesion Success
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start19 Mar 2019
- Primary completion8 Nov 2019
- Study completion20 May 2020
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
- 31 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
- NCT03847233
- Sponsor's protocol ID
- S2450
- Status last verified
- Aug 2021
- First submitted
- 18 Feb 2019
- Last updated
- 16 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication. The information and data, obtained from the trial is used without personal identification.
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. 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
- NCT03847233
- Acronym / sponsor ID
- S2450
- Conditions
- Peripheral Arterial Disease
- Keywords
- Superficial Femoral Artery, Proximal Popliteal Artery, Endovascular therapy, Atherectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 20 Feb 2019 (actual)
- Results
- Posted 28 Dec 2020
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 System |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 the following criteria:
- Severely calcified lesions with degree of stenosis ≥70%
- Vessel diameter ≥3.0 mm and ≤6.0 mm
- Total lesion length (or series of lesions) ≤150 mm
Key exclusion criteria (11 listed)
- 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 <80,000mm3 or >600,000mm3 as baseline assessment.
- History of myocardial infarction, or stroke/cerebrovascular accident (CVA) within 6 months prior to study enrollment
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
Number of Patients With Lesion Success
Time frame: during procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The confidentiality of records/data obtained in the trial will remain anonymous for analysis and publication. The information and data, obtained from the trial is used without personal identification.
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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
5 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 5 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 5 inclusion and 11 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 28 Dec 2020). 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?
Number of Patients With Lesion Success (time frame: during procedure). 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 16 Aug 2021.