A Study to Collect Intravascular Ultrasound Images Before and After Treatment With the Jetstream System

The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00911417

Enrollment

Registered

2009-06-01

Start date

2009-06-30

Completion date

2011-08-31

Last updated

2011-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Peripheral Vascular Disease

Keywords

peripheral arterial disease, peripheral vascular disease

Brief summary

The Jetstream System is a commercially available rotating, aspirating, expandable catheter designed to remove atherosclerotic plaque and blood clots in the lower limbs. The purpose of this study is to use intravascular ultrasound (IVUS) during the interventional procedure to measure the amount of plaque and blood clots removed by the Jetstream System.

Interventions

DEVICEPathway Jetstream Atherectomy System

The Pathway Jetstream System is a commercially available rotating, aspirating, expandable catheter for active removal of plaque and blood clots in peripheral arteries of the lower limbs.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patient is ≥ 18 years of age. * The documented peripheral vascular disease is/are located in a superficial femoral, popliteal or tibial peroneal trunk arteries in the lower limb. * The patient is an acceptable candidate for percutaneous intervention using the Jetstream G2 System in accordance with its labeled indications and instructions for use. * The patient has been informed about the nature of the study and has provided informed consent.

Exclusion criteria

* Patient has no distal runoff. * Interventional treatment is intended for in-stent restenosis at the peripheral vascular site. * Patient is pregnant or nursing a child. * Intended interventional treatment includes planned laser, brachytherapy or atherectomy procedure other than the Jetstream G2 System. * Patient has clinically significant abnormal ECG or blood test results or any other factor that would put the patient at increased risk if participating in the study.

Design outcomes

Primary

Measure	Time frame
Plaque Morphology	up to 12 month follow-up

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026