Trial Outcomes & Findings for Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II) (NCT NCT03847233)
NCT ID: NCT03847233
Last Updated: 2021-08-16
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
during procedure
Results posted on
2021-08-16
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Index Procedure
STARTED
|
31
|
|
Index Procedure
COMPLETED
|
31
|
|
Index Procedure
NOT COMPLETED
|
0
|
|
6 Month After Index Procedure
STARTED
|
31
|
|
6 Month After Index Procedure
COMPLETED
|
30
|
|
6 Month After Index Procedure
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME II)
Baseline characteristics by cohort
| Measure |
Jetstream Atherectomy System
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
31 participants
n=5 Participants
|
|
History of renal insufficiency (Hemodialysis)
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during procedurePopulation: Based on the per-protocol analysis set
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=28 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Number of Patients With Lesion Success
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsPopulation: One subject did not complete the 6-months follow-up.
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Assisted Primary Patency
1 month
|
31 Participants
|
|
Assisted Primary Patency
6 months
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsPopulation: One subject did not complete the 6-months follow-up.
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Primary Patency
1 month
|
31 Participants
|
|
Primary Patency
6 months
|
29 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsPopulation: One subject did not complete the 6-months follow-up.
Rate of Hemodynamic Improvement as assessed by changes in Ankle-Brachial Index (ABI) as compared to baseline at 1 month and 6 months
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Rate of Hemodynamic Improvement
6 months
|
22 Participants
|
|
Rate of Hemodynamic Improvement
1 month
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsPopulation: One subject did not complete the 6-months follow-up.
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Rate of Primary Sustained Clinical Improvement
1 month
|
30 Participants
|
|
Rate of Primary Sustained Clinical Improvement
6 months
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsPopulation: One subject did not complete the 6-months follow-up.
Distribution of Rutherford Class at 1 month and 6 months
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Distribution of Rutherford Class
1 month · Category 0 (Asymptomatic)
|
25 Participants
|
|
Distribution of Rutherford Class
1 month · Category 1 (Mild claudication)
|
4 Participants
|
|
Distribution of Rutherford Class
1 month · Category 2 (Moderate claudication)
|
2 Participants
|
|
Distribution of Rutherford Class
6 months · Category 0 (Asymptomatic)
|
24 Participants
|
|
Distribution of Rutherford Class
6 months · Category 1 (Mild claudication)
|
5 Participants
|
|
Distribution of Rutherford Class
6 months · Category 2 (Moderate claudication)
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Adverse Event Rates
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsOutcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
1 month
|
0 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR) Rate
6 months
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsOutcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Clinically-driven TLR Rate
1 month
|
0 Participants
|
|
Clinically-driven TLR Rate
6 months
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 month and 6 monthsAll-cause death through 1 month, and/or target limb major amputation and/or Target Lesion Revascularization (TLR) through 6 months
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Major Adverse Event (MAE) Rate
1 month
|
0 Participants
|
|
Major Adverse Event (MAE) Rate
6 months
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at prior to treatment with Jetstream and after treatment with JetstreamChange 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).
Outcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Reduction in Lesion Stenosis
|
34.6 percent diameter stenosis
Standard Deviation 16.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during procedure or within 24 hours post-index procedureOutcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Number of Patients With Distal Emboli Requiring Additional Treatment
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during procedureOutcome measures
| Measure |
Jetstream Atherectomy System on the PP Analysis Set
n=31 Participants
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Number of Patients With Procedural Success
|
31 Participants
|
Adverse Events
Jetstream Atherectomy System on the ITT Analysis Set
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Jetstream Atherectomy System on the ITT Analysis Set
n=31 participants at risk
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
3.2%
1/31 • 6 months
|
|
Cardiac disorders
Coronary artery thrombosis
|
3.2%
1/31 • 6 months
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • 6 months
|
|
Injury, poisoning and procedural complications
Fracture
|
3.2%
1/31 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer recurrent
|
3.2%
1/31 • 6 months
|
|
Vascular disorders
Peripheral artery occlusion
|
3.2%
1/31 • 6 months
|
Other adverse events
| Measure |
Jetstream Atherectomy System on the ITT Analysis Set
n=31 participants at risk
Jetstream Atherectomy System: A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
|
|---|---|
|
Vascular disorders
Peripheral embolism
|
9.7%
3/31 • 6 months
|
Additional Information
Yoko Takizawa/Clinical Project Manager
Boston Scientific Japan K.K.
Phone: +81-3-6853-7500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER