Trial Outcomes & Findings for Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME) (NCT NCT02733653)

NCT ID: NCT02733653

Last Updated: 2019-01-08

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-01-08

Participant Flow

Sixty patients including 10 roll-in patients were enrolled in this trial. Roll-in patients are not included in the endpoint analyses.

Participant milestones

Measure	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
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Jetstream Atherectomy System (J-SUPREME)

Baseline characteristics by cohort

Measure	Jetstream Atherectomy System - Primary Subject n=50 Participants 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
Age, Continuous	72.3 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	50 Participants n=5 Participants
Region of Enrollment Japan	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Jetstream Atherectomy System - Primary Subject n=47 Participants 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
Primary Patency Rate	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during procedure

Bailout stenting or surgical procedure during the index procedure is not needed

Outcome measures

Measure	Jetstream Atherectomy System - Primary Subject n=50 Participants 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
Procedural Success Rate	50 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during procedure or within 24 hours post-index procedure

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: during procedure

The difference between the percent stenosis prior to treatment with Jetstream and the percent stenosis following treatment with Jetstream.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Measure	Jetstream Atherectomy System - Primary Subject n=49 Participants 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
Major Adverse Event (MAE) Rate MAE at 6 months	5 Participants
Major Adverse Event (MAE) Rate MAE at 12 months	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month, 6 months and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month, 6 months and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month, 6 months and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months and 12 months

Distribution of Rutherford Class as compared to baseline at 6 months and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month, 6 months and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month, 6 months and 12 months

Outcome measures

Outcome data not reported

Adverse Events

Jetstream Atherectomy System - Primary Subject

Serious events: 25 serious events

Other events: 24 other events

Deaths: 1 deaths

Serious adverse events

Measure	Jetstream Atherectomy System - Primary Subject n=50 participants at risk 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
Vascular disorders Peripheral artery occlusion	12.0% 6/50 • 12 months
Vascular disorders Peripheral artery stenosis	16.0% 8/50 • 12 months
Vascular disorders Arterial intramural haematoma	2.0% 1/50 • 12 months
Vascular disorders Peripheral arterial occlusive disease	2.0% 1/50 • 12 months
Cardiac disorders Angina pectoris	10.0% 5/50 • 12 months
Cardiac disorders Acute myocardial infarction	2.0% 1/50 • 12 months
Cardiac disorders Coronary artery stenosis	2.0% 1/50 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	4.0% 2/50 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.0% 1/50 • 12 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	2.0% 1/50 • 12 months
Infections and infestations Pyelonephritis	2.0% 1/50 • 12 months
Infections and infestations Pyelonephritis acute	2.0% 1/50 • 12 months
Nervous system disorders Carpal tunnel syndrome	2.0% 1/50 • 12 months
Nervous system disorders Subarachnoid haemorrhage	2.0% 1/50 • 12 months
Musculoskeletal and connective tissue disorders Trigger finger	2.0% 1/50 • 12 months
Cardiac disorders Atrial fibrillation	2.0% 1/50 • 12 months
Cardiac disorders Cardiac failure	2.0% 1/50 • 12 months
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	4.0% 2/50 • 12 months
Blood and lymphatic system disorders Iron deficiency anaemia	2.0% 1/50 • 12 months
Hepatobiliary disorders Cholecystitis acute	2.0% 1/50 • 12 months
Metabolism and nutrition disorders Diabetes mellitus	2.0% 1/50 • 12 months

Other adverse events

Measure	Jetstream Atherectomy System - Primary Subject n=50 participants at risk 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
Vascular disorders Peripheral artery stenosis	22.0% 11/50 • 12 months
Vascular disorders Peripheral embolism	6.0% 3/50 • 12 months
Infections and infestations Nasopharyngitis	14.0% 7/50 • 12 months
Injury, poisoning and procedural complications Vascular procedure complication	6.0% 3/50 • 12 months

Additional Information

Yoko Takizawa/Clinical Project Manager

Boston Scientific Japan K.K.

Phone: +81-3-6853-7500

Email: Yoko.Takizawa@bsci.com

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 trial to be in public.
• Publication restrictions are in place

Restriction type: OTHER