Trial Outcomes & Findings for The Jetstream G3™ Calcium Study (NCT NCT01273623)

NCT ID: NCT01273623

Last Updated: 2015-11-18

Results Overview

lumen area change as measured by intravascular ultrasound (IVUS)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 55 participants
• Primary outcome timeframe: Day 0
• Results posted on: 2015-11-18

Participant Flow

Participant milestones

Measure	Single Arm subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
Overall Study STARTED	55
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Measure	Single Arm subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
Overall Study did not meet IVUS criteria	29

Baseline Characteristics

The Jetstream G3™ Calcium Study

Baseline characteristics by cohort

Measure	Single Arm n=26 Participants subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
Age, Continuous	73 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

lumen area change as measured by intravascular ultrasound (IVUS)

Outcome measures

Measure	Pre-atherectomy n=26 Participants prior to Jetstream use	Post-atherectomy n=26 Participants after Jetstream use and prior to adjunctive therapies
Luminal Area Change	5.1 mm^2 Standard Deviation 2.8	8.3 mm^2 Standard Deviation 2.6

SECONDARY outcome

Timeframe: Day 0

Outcome measures

Measure	Pre-atherectomy n=26 Participants prior to Jetstream use	Post-atherectomy after Jetstream use and prior to adjunctive therapies
Adjunctive Therapy Use Percutaneous Transluminal Angioplasty	62 percentage of participants	—
Adjunctive Therapy Use Stent	31 percentage of participants	—
Adjunctive Therapy Use Other devices or procedures	8 percentage of participants	—

SECONDARY outcome

Timeframe: Day 0

lumen diameter stenosis change post-atherectomy

Outcome measures

Measure	Pre-atherectomy n=26 Participants prior to Jetstream use	Post-atherectomy after Jetstream use and prior to adjunctive therapies
Residual Diameter Stenosis	-37 percentage change Standard Deviation 13	—

Adverse Events

Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Study Participants n=26 participants at risk
Surgical and medical procedures Death	0.00% 0/26 • through 30 days
Cardiac disorders Myocardial infarction	0.00% 0/26 • through 30 days
Surgical and medical procedures Unplanned amputation	0.00% 0/26 • through 30 days
Surgical and medical procedures Target lesion revascularization	0.00% 0/26 • through 30 days

Other adverse events

Adverse event data not reported

Additional Information

Susanna Kennedy

Boston Scientific

Phone: 763.494.2601

Email: susanna.kennedy@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60