AtherosclerosisNCT03455855
Jetstream in Treatment of Occlusive Atherosclerotic Lesions in the SFA and/or PPA
A study testing Jetstream System in people with Atherosclerosis, run by Boston Scientific Corporation at 1 site in China.
Trial summary
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Jetstream System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2018to 27 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age 18 and older
- Subject or the subject's legal representative is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
- Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention
- Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment:
- Atherosclerotic lesion with diameter stenosis ≥70% ii. Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course by physicians performed, based on visual estimate iii. Minimum vessel diameter proximal to the lesion ≥ 3 mm and < and =6 mm iv. Lesion length of single or multiple focal stenosis or chronic total occlusion (CTO) lesion can be up to 15 cm long v. Target lesion located at least 3 cm above the inferior edge of the femur
- Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better with at least one of three vessels patent (< 50% stenosis by visual assessment) to the ankle or foot with no planned intervention
Who cannot join
- Target lesion is located in the iliac artery or above the SFA
- Target lesion stenosis < 70%
- Target lesion is moderately to severely angulated (> 30°) or torturous at treatment segment
- Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure
- Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to the index procedure
- Target lesion/vessel with in-stent restenosis
Show all 26Show fewer
- Subjects who have undergone prior surgery or endovascular intervention of SFA/PPA in the target limb to treat atherosclerotic disease within 3 month prior to the index procedure
- Use of drug-coated devices, or laser or any other debulking devices other than Jetstream System (such as CTO devices or cutting balloon) in the target limb during the index procedure
- History of major amputation in the target limb
- Documented life expectancy less than 12 months due to other medical co-morbid condition(s)
- Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
- Known history of coagulopathy or hypercoagulable bleeding disorder
- Known hypersensitivity/allergy to the investigational devices or protocol related therapies (e.g., nitinol, stainless steel or other stent materials, and antiplatelet, anticoagulant, thrombolytic medications)
- Platelet count < 80,000 mm3 or > 600,000 mm3 or history of bleeding diathesis
- Undergoing hemodialysis or concomitant renal failure with a serum creatinine > 2.0 mg/dL (176.8umol/L)
- History of myocardial infarction (MI), stroke/cerebrovascular accident (CVA) or gastrointestinal bleeding within 6 months prior to the enrollment
- Unstable angina pectoris at the time of enrollment.
- History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within past 14 days
- Pregnant, breast feeding, or plan to become pregnant in the next 12 months
- Current participation in another investigational drug or device clinical study that has not completed the primary endpoint at the time of enrollment or that clinically interferes with the current study endpoints (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)
- Septicemia at the time of enrollment
- Presence of outflow lesions in the target limb requiring intervention during the index procedure
- Presence of other hemodynamically significant lesions in the target limb requiring intervention within 30 days of enrollment
- Acute ischemia and/or acute thrombosis of the target lesion/vessel prior to the index procedure
- Presence of aneurysm in the target vessel
- Perforated vessel as evidenced by extravasation of contrast media prior to the enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-randomized, Multicenter Clinical Study of the JETSTREAM™ Atherectomy System (Jetstream) in Treatment of Occlusive Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries in Chinese Patients
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.
Read the detailed description
study objectives: To evaluate the safety and effectiveness of JETSTREAM™ Atherectomy System (Jetstream) for treating symptomatic Chinese patients with occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA)during percutaneous peripheral vascular intervention.
Planed Indications for use: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA.
Primary Safety Endpoint: Major Adverse Event (MAE), defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure
Primary Effectiveness Endpoint: Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
- Conditions
- Atherosclerosis
- Being tested
- Jetstream System
- Keywords
- Atherectomy, occlusive atherosclerotic lesions
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jetstream SystemDevice
including Atherectomy Console (Jetstream Console) and Atherectomy Catheter(Jetstream Catheter), intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA.
| Study group | Role | What they receive |
|---|---|---|
| treated with the Jetstream System | Experimental | It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System. Receives: Device: Jetstream System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis
Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
Measured: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up
defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure.
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start5 Mar 2018
- Primary completion22 Feb 2023
- Study completion27 Jan 2024
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 AtherosclerosisStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Guo, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455855
- Sponsor's protocol ID
- S6050
- Status last verified
- Oct 2024
- First submitted
- 24 Feb 2018
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Multicenter Clinical Study of the JETSTREAM™ Atherectomy System (Jetstream) in Treatment of Occlusive Atherosclerotic Lesions in the Superficial Femoral and/or Proximal Popliteal Arteries in Chinese Patients
- ClinicalTrials.gov ID
- NCT03455855
- Acronym / sponsor ID
- S6050
- Conditions
- Atherosclerosis
- Keywords
- Atherectomy, occlusive atherosclerotic lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 7 Mar 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.
Detailed description
study objectives: To evaluate the safety and effectiveness of JETSTREAM™ Atherectomy System (Jetstream) for treating symptomatic Chinese patients with occlusive atherosclerotic lesions in native superficial femoral artery (SFA) and/ or proximal popliteal arteries (PPA)during percutaneous peripheral vascular intervention.
Planed Indications for use: The Jetstream System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA.
Primary Safety Endpoint: Major Adverse Event (MAE), defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure
Primary Effectiveness Endpoint: Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated with the Jetstream System | Experimental | Device: Jetstream SystemIt is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age 18 and older
- Subject or the subject's legal representative is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
- Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention
- Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment:
- Patent infrapopliteal and popliteal artery, i.e., single distal runoff or better with at least one of three vessels patent (< 50% stenosis by visual assessment) to the ankle or foot with no planned intervention
Key exclusion criteria (26 listed)
- Target lesion is located in the iliac artery or above the SFA
- Target lesion stenosis < 70%
- Target lesion is moderately to severely angulated (> 30°) or torturous at treatment segment
- Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure
- Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to 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 Systemincluding Atherectomy Console (Jetstream Console) and Atherectomy Catheter(Jetstream Catheter), intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA. | Device | treated with the Jetstream System |
Primary outcome
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis
Time frame: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up
Time frame: 30days
defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wei Guo principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jetstream System in people with Atherosclerosis, run by Boston Scientific Corporation at 1 site in China.
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 6 inclusion and 26 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 19 Sep 2024). 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?
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis (time frame: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))). The study lists 2 primary outcomes in all. 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 29 Oct 2024.