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

Phase 4

Completed

• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease

• Registration Number: NCT00911417
• Lead Sponsor: Pathway Medical Technologies Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-28
• Study Start: 2009-06
• Study First Posted: 2009-06-01
• Primary Completion: 2011-07
• Study Completion: 2011-08
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-02
• Last Update Posted: 2011-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Plaque Morphology	up to 12 month follow-up

Trial Locations

Locations (5)

St. John's Hospital; 🇺🇸 Springfield, Illinois, United States

Arizona Heart Institute; 🇺🇸 Phoenix, Arizona, United States

Mount Sinai Medical Center; 🇺🇸 New York City, New York, United States

St. John Hospital & Medical Ctr.; 🇺🇸 Detroit, Michigan, United States

St. Luke's Hospital; 🇺🇸 Phoenix, Arizona, United States