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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00911417
Other study ID # PTC09030
Secondary ID
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


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
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