Atherosclerosis
Conditions
Keywords
Atherectomy, occlusive atherosclerotic lesions
Brief 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 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).
Interventions
DEVICEJetstream System
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.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects age 18 and older 2. 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 3. Subject has documented chronic, symptomatic lower limb ischemia defined as Rutherford categories 2 - 4, and is eligible for percutaneous peripheral vascular intervention 4. Stenotic, restenotic or occlusive lesion(s) located in the native SFA and/or PPA, and meet all of following angiographic criteria by visual assessment: i. 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 5. 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
Exclusion criteria
1. Target lesion is located in the iliac artery or above the SFA 2. Target lesion stenosis \< 70% 3. Target lesion is moderately to severely angulated (\> 30°) or torturous at treatment segment 4. Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to the index procedure 5. Target lesion/vessel previously treated with atherectomy, laser or other debulking devices prior to the index procedure 6. Target lesion/vessel with in-stent restenosis 7. 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 8. 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 9. History of major amputation in the target limb 10. Documented life expectancy less than 12 months due to other medical co-morbid condition(s) 11. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated 12. Known history of coagulopathy or hypercoagulable bleeding disorder 13. 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) 14. Platelet count \< 80,000 mm3 or \> 600,000 mm3 or history of bleeding diathesis 15. Undergoing hemodialysis or concomitant renal failure with a serum creatinine \> 2.0 mg/dL (176.8umol/L) 16. History of myocardial infarction (MI), stroke/cerebrovascular accident (CVA) or gastrointestinal bleeding within 6 months prior to the enrollment 17. Unstable angina pectoris at the time of enrollment. 18. History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within past 14 days 19. Pregnant, breast feeding, or plan to become pregnant in the next 12 months 20. 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) 21. Septicemia at the time of enrollment 22. Presence of outflow lesions in the target limb requiring intervention during the index procedure 23. Presence of other hemodynamically significant lesions in the target limb requiring intervention within 30 days of enrollment 24. Acute ischemia and/or acute thrombosis of the target lesion/vessel prior to the index procedure 25. Presence of aneurysm in the target vessel 26. Perforated vessel as evidenced by extravasation of contrast media prior to the enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis | 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 | 30days | defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure. |
Countries
China
Participant flow
Recruitment details
Participants were recruited based on physician referral at 6 sites between Feb 2018 and Jan 2024. The first participant was enrolled on 5 Mar 2018 and the last participant was enrolled on 10 Jan 2023.
Pre-assignment details
Approximately 80 subjects (including 20 roll-in subjects) in 10 sites planned to be enrolled. The sample of primary cohort is 60. The sample of roll in cohort depends on the site number. 2 roll-in subjects per site is required. Actually 6 site participated in this study, totally there are 72 subjects in all.
Participants by arm
| Arm | Count |
|---|---|
| Primary Cohort The overall sample size is consist of the primary cohort and roll-in subjects. A sample size of 60 subjects to be enrolled in the primary cohort at baseline. | 60 |
| Roll in Cohort The overall sample size is consist of the primary cohort and roll-in subjects. With additional 2 roll-in subjects per site and 6 sites are eligible for enrollment. | 12 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
Baseline characteristics
| Characteristic | Roll in Cohort | Total | Primary Cohort |
|---|---|---|---|
| Age, Continuous | 64.9 years | 67.1 years | 67.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 72 Participants | 60 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Male | 7 Participants | 57 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 12 |
| other Total, other adverse events | 45 / 60 | 11 / 12 |
| serious Total, serious adverse events | 21 / 60 | 8 / 12 |
Outcome results
Primary
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).
Time frame: Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
Population: 57/60 subjects from primary cohort and 11/12 subjects from roll in cohort received primary effectiveness endpoint analysis from core lab.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Cohort | The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis | 39.3 percentage of DS(diameter stenosis) | Standard Deviation 16.1 |
| Roll in Cohort | The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis | 42.8 percentage of DS(diameter stenosis) | Standard Deviation 11.1 |
| Overall Cohort | The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter Stenosis | 39.9 percentage of DS(diameter stenosis) | Standard Deviation 15.4 |
Primary
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.
Time frame: 30days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Cohort | The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up | 60 Participants |
| Roll in Cohort | The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up | 11 Participants |
| Overall Cohort | The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow up | 71 Participants |