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 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
Exclusion criteria
* 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 * 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 |
|---|---|
| Number of Patients With Lesion Success | during procedure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 1 month and 6 months | — |
| Rate of Hemodynamic Improvement | 1 month and 6 months | Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) as compared to baseline at 1 month and 6 months |
| Rate of Primary Sustained Clinical Improvement | 1 month and 6 months | — |
| Distribution of Rutherford Class | 1 month and 6 months | Distribution of Rutherford Class at 1 month and 6 months |
| Adverse Event Rates | 6 months | — |
| Assisted Primary Patency | 1 month and 6 months | — |
| Clinically-driven TLR Rate | 1 month and 6 months | — |
| Major Adverse Event (MAE) Rate | 1 month and 6 months | All-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 6 months |
| Reduction in Lesion Stenosis | Assessed at prior to treatment with Jetstream and after treatment with Jetstream | Change in the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream (Reduction in Lesion Stenosis=Pre-Jetstream percent stenosis - Post-Jetstream percent stenosis). |
| Number of Patients With Distal Emboli Requiring Additional Treatment | during procedure or within 24 hours post-index procedure | — |
| Number of Patients With Procedural Success | during procedure | — |
| Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 month and 6 months | — |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Jetstream Atherectomy System Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | Jetstream Atherectomy System |
|---|---|
| Age, Continuous | 72.5 years STANDARD_DEVIATION 7.7 |
| History of renal insufficiency (Hemodialysis) | 7 Participants |
| Race/Ethnicity, Customized Japanese | 31 Participants |
| Region of Enrollment Japan | 31 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 31 |
| other Total, other adverse events | 3 / 31 |
| serious Total, serious adverse events | 3 / 31 |
Outcome results
Primary
Number of Patients With Lesion Success
Time frame: during procedure
Population: Based on the per-protocol analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Number of Patients With Lesion Success | 22 Participants |
Other Pre-specified
Adverse Event Rates
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Adverse Event Rates | 16 Participants |
Other Pre-specified
Assisted Primary Patency
Time frame: 1 month and 6 months
Population: One subject did not complete the 6-months follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Assisted Primary Patency | 1 month | 31 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Assisted Primary Patency | 6 months | 29 Participants |
Other Pre-specified
Clinically-driven Target Vessel Revascularization (TVR) Rate
Time frame: 1 month and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 month | 0 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Clinically-driven Target Vessel Revascularization (TVR) Rate | 6 months | 0 Participants |
Other Pre-specified
Clinically-driven TLR Rate
Time frame: 1 month and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Clinically-driven TLR Rate | 1 month | 0 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Clinically-driven TLR Rate | 6 months | 0 Participants |
Other Pre-specified
Distribution of Rutherford Class
Distribution of Rutherford Class at 1 month and 6 months
Time frame: 1 month and 6 months
Population: One subject did not complete the 6-months follow-up.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Distribution of Rutherford Class | 1 month | Category 0 (Asymptomatic) | 25 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Distribution of Rutherford Class | 1 month | Category 1 (Mild claudication) | 4 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Distribution of Rutherford Class | 1 month | Category 2 (Moderate claudication) | 2 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Distribution of Rutherford Class | 6 months | Category 0 (Asymptomatic) | 24 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Distribution of Rutherford Class | 6 months | Category 1 (Mild claudication) | 5 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Distribution of Rutherford Class | 6 months | Category 2 (Moderate claudication) | 1 Participants |
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 6 months
Time frame: 1 month and 6 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Major Adverse Event (MAE) Rate | 6 months | 0 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Major Adverse Event (MAE) Rate | 1 month | 0 Participants |
Other Pre-specified
Number of Patients With Distal Emboli Requiring Additional Treatment
Time frame: during procedure or within 24 hours post-index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Number of Patients With Distal Emboli Requiring Additional Treatment | 2 Participants |
Other Pre-specified
Number of Patients With Procedural Success
Time frame: during procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Number of Patients With Procedural Success | 31 Participants |
Other Pre-specified
Primary Patency
Time frame: 1 month and 6 months
Population: One subject did not complete the 6-months follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Primary Patency | 1 month | 31 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Primary Patency | 6 months | 29 Participants |
Other Pre-specified
Rate of Hemodynamic Improvement
Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) as compared to baseline at 1 month and 6 months
Time frame: 1 month and 6 months
Population: One subject did not complete the 6-months follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Rate of Hemodynamic Improvement | 6 months | 22 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Rate of Hemodynamic Improvement | 1 month | 23 Participants |
Other Pre-specified
Rate of Primary Sustained Clinical Improvement
Time frame: 1 month and 6 months
Population: One subject did not complete the 6-months follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Rate of Primary Sustained Clinical Improvement | 1 month | 30 Participants |
| Jetstream Atherectomy System on the PP Analysis Set | Rate of Primary Sustained Clinical Improvement | 6 months | 30 Participants |
Other Pre-specified
Reduction in Lesion Stenosis
Change in the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream (Reduction in Lesion Stenosis=Pre-Jetstream percent stenosis - Post-Jetstream percent stenosis).
Time frame: Assessed at prior to treatment with Jetstream and after treatment with Jetstream
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Jetstream Atherectomy System on the PP Analysis Set | Reduction in Lesion Stenosis | 34.6 percent diameter stenosis | Standard Deviation 16 |