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

Peripheral Arterial Disease Clinical Trial

Official title:

The Jetstream G2 System Post-Market Peripheral Vascular IVUS Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911417
• Other study ID #: PTC09030
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2009
• Last updated: September 2, 2011
• Start date: June 2009
• Est. completion date: August 2011

Study information

• Verified date: September 2011
• Source: Pathway Medical Technologies Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	St. John Hospital & Medical Ctr.	Detroit	Michigan
United States	Mount Sinai Medical Center	New York City	New York
United States	Arizona Heart Institute	Phoenix	Arizona
United States	St. Luke's Hospital	Phoenix	Arizona
United States	St. John's Hospital	Springfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Pathway Medical Technologies Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque Morphology		up to 12 month follow-up	No