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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier:
NCT00911417
First received: May 19, 2009
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Peripheral Arterial Disease
Peripheral Vascular Disease
Device: Pathway Jetstream Atherectomy System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study

Resource links provided by NLM:


Further study details as provided by Pathway Medical Technologies Inc.:

Primary Outcome Measures:
  • Plaque Morphology [ Time Frame: up to 12 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2009
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Pathway 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911417

Locations
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
St. Luke's Hospital
Phoenix, Arizona, United States, 85006
United States, Illinois
St. John's Hospital
Springfield, Illinois, United States, 62701
United States, Michigan
St. John Hospital & Medical Ctr.
Detroit, Michigan, United States, 48236
United States, New York
Mount Sinai Medical Center
New York City, New York, United States, 10029
Sponsors and Collaborators
Pathway Medical Technologies Inc.
Investigators
Principal Investigator: Tom Davis, MD St. John's Hospital and Medical Center
  More Information

No publications provided

Responsible Party: Pathway Medical Technologies Inc.
ClinicalTrials.gov Identifier: NCT00911417     History of Changes
Other Study ID Numbers: PTC09030
Study First Received: May 19, 2009
Last Updated: September 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Pathway Medical Technologies Inc.:
peripheral arterial disease
peripheral vascular disease

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 28, 2014