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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease
• Intervention / Treatment: Device: Pathway Jetstream Atherectomy System

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Heart Institute
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Hospital
  • Illinois
    • Springfield, Illinois, United States, 62701
      • St. John's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital & Medical Ctr.
  • New York
    • New York City, New York, United States, 10029
      • Mount Sinai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plaque Morphology	up to 12 month follow-up

Collaborators and Investigators

• Sponsor: Pathway Medical Technologies Inc.
• Investigators: Principal Investigator: Tom Davis, MD, St. John's Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: May 19, 2009
• First Submitted That Met QC Criteria: May 28, 2009
• First Posted (Estimate): June 1, 2009

Study Record Updates

• Last Update Posted (Estimate): September 5, 2011
• Last Update Submitted That Met QC Criteria: September 2, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: peripheral vascular disease; peripheral arterial disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: PTC09030