Peripheral Arterial Disease
Conditions
Keywords
Superficial Femoral Artery, Proximal Popliteal Artery, Endovascular therapy, Atherectomy
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).
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.
Interventions
A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in 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
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency Rate | 6 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Distal Emboli Requiring Additional Treatment | during procedure or within 24 hours post-index procedure | — |
| Reduction in Lesion Stenosis | during procedure | The difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream. |
| Major Adverse Event (MAE) Rate | 1 month, 6 months and 12 months | All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 12 months |
| Primary Patency | 1 month, 6 months and 12 months | Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or, bypass of the target lesion. |
| Assisted Primary Patency | 1 month, 6 months and 12 months | Percentage (%) of lesions without TLR and those with TLR (not due to complete occlusion or by-pass) that reach endpoint without restenosis. |
| Procedural Success Rate | during procedure | Bailout stenting or surgical procedure during the index procedure is not needed |
| Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 month, 6 months and 12 months | — |
| Adverse Event Rates | 1 month, 6 months and 12 months | — |
| Distribution of Rutherford Class | 6 months and 12 months | Distribution of Rutherford Class as compared to baseline at 6 months and 12 months |
| Rate of Primary and Secondary Sustained Clinical Improvement | 1 month, 6 months and 12 months | — |
| Rate of Hemodynamic Improvement | 1 month, 6 months and 12 months | — |
| Clinically-driven TLR Rate | 1 month, 6 months and 12 months | — |
Countries
Japan
Participant flow
Pre-assignment details
Sixty patients including 10 roll-in patients were enrolled in this trial. Roll-in patients are not included in the endpoint analyses.
Participants by arm
| Arm | Count |
|---|---|
| Jetstream Atherectomy System - Primary Subject Adjunctive therapy with Jetstream Atherectomy System for percutaneous intervention
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Jetstream Atherectomy System - Primary Subject |
|---|---|
| Age, Continuous | 72.3 years |
| Race/Ethnicity, Customized Japanese | 50 Participants |
| Region of Enrollment Japan | 50 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 50 |
| other Total, other adverse events | 24 / 50 |
| serious Total, serious adverse events | 25 / 50 |
Outcome results
Primary
Primary Patency Rate
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jetstream Atherectomy System - Primary Subject | Primary Patency Rate | 19 Participants |
Other Pre-specified
Adverse Event Rates
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Assisted Primary Patency
Percentage (%) of lesions without TLR and those with TLR (not due to complete occlusion or by-pass) that reach endpoint without restenosis.
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Clinically-driven Target Vessel Revascularization (TVR) Rate
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Clinically-driven TLR Rate
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Distribution of Rutherford Class
Distribution of Rutherford Class as compared to baseline at 6 months and 12 months
Time frame: 6 months and 12 months
Other Pre-specified
Major Adverse Event (MAE) Rate
All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 12 months
Time frame: 1 month, 6 months and 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System - Primary Subject | Major Adverse Event (MAE) Rate | MAE at 12 months | 13 Participants |
| Jetstream Atherectomy System - Primary Subject | Major Adverse Event (MAE) Rate | MAE at 6 months | 5 Participants |
Other Pre-specified
Primary Patency
Percentage (%) of lesions that reach endpoint without a hemodynamically significant stenosis on Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or, bypass of the target lesion.
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Procedural Success Rate
Bailout stenting or surgical procedure during the index procedure is not needed
Time frame: during procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jetstream Atherectomy System - Primary Subject | Procedural Success Rate | 50 Participants |
Other Pre-specified
Rate of Distal Emboli Requiring Additional Treatment
Time frame: during procedure or within 24 hours post-index procedure
Other Pre-specified
Rate of Hemodynamic Improvement
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Rate of Primary and Secondary Sustained Clinical Improvement
Time frame: 1 month, 6 months and 12 months
Other Pre-specified
Reduction in Lesion Stenosis
The difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream.
Time frame: during procedure