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

Pathway Medical Technologies

Status and phase

Completed

Phase 4

Conditions

Peripheral Vascular Disease

Peripheral Arterial Disease

Treatments

Device: Pathway Jetstream Atherectomy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00911417

PTC09030

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.