Trial Outcomes & Findings for The Jetstream (JET) Post-market Registry (NCT NCT01436435)

Results Overview

Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \>2.5. Binary restenosis will be measured by duplex ultrasound technology.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

241 participants

Primary outcome timeframe

12 months

Results posted on

2016-10-19

Participant Flow

Participant milestones

Participant milestones
Measure	Jetstream Atherectomy System Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Overall Study STARTED	241
Overall Study COMPLETED	177
Overall Study NOT COMPLETED	64

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Jetstream (JET) Post-market Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Jetstream Atherectomy System n=241 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Age, Continuous	67.1 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	159 Participants n=5 Participants
Region of Enrollment United States	241 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 184 participants were not evaluable.

Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio \>2.5. Binary restenosis will be measured by duplex ultrasound technology.

Outcome measures

Outcome measures
Measure	Jetstream Atherectomy System n=57 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Binary Restenosis	22.8 percentage of patients

SECONDARY outcome

Timeframe: Index Procedure

Population: Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy

Outcome measures

Outcome measures
Measure	Jetstream Atherectomy System n=241 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Procedural Success	98.3 percentage of patients

SECONDARY outcome

Timeframe: 30 days

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.

Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.

Outcome measures

Outcome measures
Measure	Jetstream Atherectomy System n=219 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Ankle-Brachial Index (ABI)	73.5 percentage of patients

SECONDARY outcome

Timeframe: 6 months

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 51 participants were not evaluable.

Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.

Outcome measures

Outcome measures
Measure	Jetstream Atherectomy System n=190 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Ankle-Brachial Index (ABI)	54.7 percentage of patients

SECONDARY outcome

Timeframe: 12 months

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 64 participants were not evaluable.

Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.

Outcome measures

Outcome measures
Measure	Jetstream Atherectomy System n=177 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Ankle-Brachial Index (ABI)	58.2 percentage of patients

SECONDARY outcome

Timeframe: 30 days

Population: Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 22 participants were not evaluable.

Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days

Outcome measures

Outcome measures
Measure	Jetstream Atherectomy System n=219 Participants Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Major Adverse Events (MAE)	5 Major Adverse Events

Adverse Events

Jetstream Atherectomy System

Serious events: 42 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Jetstream Atherectomy System n=241 participants at risk Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Vascular disorders Target Vessel Revascularization/ Target Lesion Revascularization	15.8% 38/241 • Number of events 38 • Index procedure through 12 month follow up
Vascular disorders Distal Embolization Requiring a Separate Intervention	1.2% 3/241 • Number of events 3 • Index procedure through 12 month follow up
Surgical and medical procedures Amputation	0.41% 1/241 • Number of events 1 • Index procedure through 12 month follow up

Other adverse events

Other adverse events
Measure	Jetstream Atherectomy System n=241 participants at risk Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy. Jetstream Atherectomy System: Atherectomy
Vascular disorders Peripheral Artery Disease	15.8% 38/241 • Number of events 49 • Index procedure through 12 month follow up

Additional Information

DeeAnn Tinjum, Clinical Trial Manager

Boston Scientific

Phone: 763-494-1927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place