The Jetstream (JET) Post-market Registry (JET)

September 3, 2016 updated by: Boston Scientific Corporation

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington DC, District of Columbia, United States, 20010
        • Nelson Bernardo MD
    • Florida
      • Miami, Florida, United States, 33141
        • Robert Beasley, MD
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Nicolas Shammas, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Lawrence Garcia, MD
    • Mississippi
      • Laurel, Mississippi, United States, 39440
        • Vinay Kumar
    • New Jersey
      • Flemington, New Jersey, United States, 08822
        • Andrey Espinoza, MD
    • New York
      • Huntington, New York, United States, 11734
        • Sotir Polena, MD
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Rajesh Dave, MD
      • West Reading, Pennsylvania, United States, 19611
        • Ali Amin, MD
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Lee Butterfield, MD
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Chris Metzger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • Patient has had severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  • Patient has had surgical or endovascular procedure in the same vascular territory within 30 days prior to the index procedure.
  • Patient has any planned surgical intervention or endovascular procedure within 30 days after the index procedure.
  • Use of another debulking device during the index procedure prior to the Jetstream NAVITUS System will exclude the patient.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Jetstream Atherectomy System
Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Device: Jetstream Atherectomy System
Atherectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Binary Restenosis
Time Frame: 12 months
Percentage of patients with binary restenosis at 12 months as defined by duplex ultrasound derived systolic velocity ratio >2.5. Binary restenosis will be measured by duplex ultrasound technology.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedural Success
Time Frame: Index Procedure
Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
Index Procedure
Ankle-Brachial Index (ABI)
Time Frame: 30 days
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
30 days
Ankle-Brachial Index (ABI)
Time Frame: 6 months
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
6 months
Ankle-Brachial Index (ABI)
Time Frame: 12 months
Improvement in Ankle-Brachial Index (ABI) by ≥0.10 from the pre-procedure value. ABI is a quick, non-invasive test that compares your blood pressure measured at your ankle with your blood pressure measured at your arm.
12 months
Major Adverse Events (MAE)
Time Frame: 30 days
Number of Major Adverse Events as defined by amputation, death, Target Lesion Revascularization, Target Vessel Revascularization, Myocardial Infarction or angiographic distal embolization that requires a separate intervention or hospitalization through 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D1465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings