Loading clinical trials...

The Jetstream (JET) Post-market Registry | Clinical Trials | Clareo Health

COMPLETEDPHASE4

The Jetstream (JET) Post-market Registry

Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)

NCT01436435•Boston Scientific Corporation

Summary

The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.

Detailed Description

* To observe the treatment effects of the Jetstream NAVITUS System in long, occluded, diffuse, thrombotic or calcified lesions in peripheral arterial disease of the common femoral, superficial femoral, or popliteal arteries. * To assess and quantify vessel patency 1 year post atherectomy treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is ≥ 18 years of age.
•The target de novo or restenotic Percutaneous Transluminal Angioplasty (PTA) lesion(s) is/are located in the common femoral, superficial femoral or popliteal arteries.
•The reference vessel lumen (proximal to target lesion) is ≥ 4.0mm.
•Evidence of ≥ 70% stenosis or occlusion confirmed by angiography.
•Guidewire must cross lesion(s) within the true lumen, without a sub-intimal course before the patient is considered as entered into the study.
•Patient is an acceptable candidate for percutaneous intervention using the Jetstream NAVITUS System in accordance with its labeled indications and instructions for use.
•Lesion length ≥ 4cm.
•Patient has a Rutherford category score of 1-3.
•Patient has signed approved informed consent.
•Patient is willing to comply with the follow-up evaluations at specified times.

Exclusion Criteria

•Patient has an uncontrollable allergy to nitinol, stainless steel or other stent materials or to contrast agent.
•Patient is unable to take appropriate anti-platelet therapy.
•Patient has no patent distal runoff vessels.
•Patient has critical limb ischemia (i.e., Rutherford class 4-6)
•Limited vascular access that precludes safe advancement of the Jetstream NAVITUS System to the target lesion(s).
•Interventional treatment is intended for in-stent restenosis.
•Patient has target vessel with moderate or severe angulation (e.g., \>30 degrees) or tortuosity at the treatment segment.
•Patient has a history of coagulopathy or hypercoagulable bleeding disorder.
•Patient is receiving hemodialysis or has significantly impaired renal function (creatinine is \> 2.5 mg/dl) at the time of treatment.
•Patient has evidence of intracranial or gastrointestinal bleeding within the past 3 months.
+4 more criteria

Locations (11)

Nelson Bernardo MD

Washington D.C., District of Columbia, United States

Robert Beasley, MD

Miami, Florida, United States

Nicolas Shammas, MD

Davenport, Iowa, United States

Lawrence Garcia, MD

Boston, Massachusetts, United States

Vinay Kumar

Laurel, Mississippi, United States

Andrey Espinoza, MD

Flemington, New Jersey, United States

Sotir Polena, MD

Huntington, New York, United States

Rajesh Dave, MD

Harrisburg, Pennsylvania, United States

Ali Amin, MD

West Reading, Pennsylvania, United States

Lee Butterfield, MD

Columbia, South Carolina, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

February 1, 2016

Completion Date

February 1, 2016

Last Updated

October 19, 2016

Enrollment

241

ACTUAL participants

Conditions

Peripheral Arterial Diseases

Interventions

Jetstream Atherectomy System

DEVICE

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

NCT07322913

Carotid Artery DiseasesAortic Diseases+1 more

View study

RECRUITINGPHASE4

Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

NCT06777901

Peripheral Arterial Diseases

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Jetstream (JET) Post-market Registry

Inclusion Criteria

Exclusion Criteria

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

Transcutaneous Oxygen Pressure (TcPO2) Determination.