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Completed

NCT Number: NCT00911417

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Arizona Heart Institute, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pathway Jetstream Atherectomy System

Device

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.

Primary outcomes

  1. Plaque Morphology

    Time frame: up to 12 month follow-up

Sponsors and collaborators

Lead sponsor

Pathway Medical Technologies Inc.

Industry

Registry information

Official study title

The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 1, 2009
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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