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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jetstream Atherectomy System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jetstream Atherectomy System | Device | A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Lesion Success | during procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Assisted Primary Patency | 1 month and 6 months | |
| Primary Patency | 1 month and 6 months | |
| Rate of Hemodynamic Improvement |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazushi Urasawa, MD, PhD | Tokeidai Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Bay Urayasu Ichikawa Medical Center | Urayasu | Chiba | 279-0001 | Japan | ||
| Kokura Memorial Hospital |
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Index Procedure |
| |||||||||||||
| 6 Month After Index Procedure |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Lesion Success | Based on the per-protocol analysis set | Posted | Count of Participants | Participants | during procedure |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Jetstream Atherectomy System on the ITT Analysis Set | Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral embolism | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoko Takizawa/Clinical Project Manager | Boston Scientific Japan K.K. | +81-3-6853-7500 | Yoko.Takizawa@bsci.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2019 | Dec 2, 2020 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 13, 2019 | Dec 2, 2020 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) as compared to baseline at 1 month and 6 months |
| 1 month and 6 months |
| Rate of Primary Sustained Clinical Improvement | 1 month and 6 months |
| Distribution of Rutherford Class | Distribution of Rutherford Class at 1 month and 6 months | 1 month and 6 months |
| Adverse Event Rates | 6 months |
| Clinically-driven Target Vessel Revascularization (TVR) Rate | 1 month and 6 months |
| Clinically-driven TLR Rate | 1 month and 6 months |
| 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 | 1 month and 6 months |
| 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). | Assessed at prior to treatment with Jetstream and after treatment with Jetstream |
| 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 |
| Kokura |
| Fukuoka |
| 802-8555 |
| Japan |
| Tokeidai Memorial Hospital | Sapporo | Hokkaido | 060-0031 | Japan |
| Kansai Rosai Hospital | Amagasaki | Hyōgo | 660-8511 | Japan |
| Kasukabe Chuo General Hospital | Kasukabe | Saitama | 344-0063 | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| History of renal insufficiency (Hemodialysis) | Count of Participants | Participants |
|
|
| Other Pre-specified | Assisted Primary Patency | One subject did not complete the 6-months follow-up. | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| Other Pre-specified | Primary Patency | One subject did not complete the 6-months follow-up. | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| 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 | One subject did not complete the 6-months follow-up. | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| Other Pre-specified | Rate of Primary Sustained Clinical Improvement | One subject did not complete the 6-months follow-up. | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| Other Pre-specified | Distribution of Rutherford Class | Distribution of Rutherford Class at 1 month and 6 months | One subject did not complete the 6-months follow-up. | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| Other Pre-specified | Adverse Event Rates | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Clinically-driven Target Vessel Revascularization (TVR) Rate | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| Other Pre-specified | Clinically-driven TLR Rate | Posted | Count of Participants | Participants | 1 month and 6 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 6 months | Posted | Count of Participants | Participants | 1 month and 6 months |
|
|
|
| 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). | Posted | Mean | Standard Deviation | percent diameter stenosis | Assessed at prior to treatment with Jetstream and after treatment with Jetstream |
|
|
|
| Other Pre-specified | Number of Patients With Distal Emboli Requiring Additional Treatment | Posted | Count of Participants | Participants | during procedure or within 24 hours post-index procedure |
|
|
|
| Other Pre-specified | Number of Patients With Procedural Success | Posted | Count of Participants | Participants | during procedure |
|
|
|
| 0 |
| 31 |
| 3 |
| 31 |
| 3 |
| 31 |
| Coronary artery thrombosis | Cardiac disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hepatic cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Peripheral artery occlusion | Vascular disorders | Systematic Assessment | Left brachial Shunt occlusion |
|
The restriction depends on the conditions on the Clinical Study Agreement at each site. The PI must notify the sponsor about the publication and receive the approval from the sponsor prior to any results/data relavant to the J-SUPREME II trial to be in public.
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Category 2 (Moderate claudication) |
|
| 6 months |
|
|