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

This study has been completed.
Information provided by (Responsible Party):
Boston Scientific Corporation Identifier:
First received: September 2, 2011
Last updated: September 3, 2016
Last verified: September 2016
The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.

Condition Intervention Phase
Peripheral Arterial Diseases
Device: Jetstream Atherectomy System
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)

Resource links provided by NLM:

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Binary Restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • Procedural Success [ Time Frame: Index Procedure ] [ Designated as safety issue: Yes ]
    Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy

  • Ankle-Brachial Index (ABI) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.

  • Ankle-Brachial Index (ABI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Ankle-Brachial Index (ABI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Major Adverse Events (MAE) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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

Enrollment: 241
Study Start Date: September 2011
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  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 identifier: NCT01436435

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

Responsible Party: Boston Scientific Corporation Identifier: NCT01436435     History of Changes
Other Study ID Numbers: D1465 
Study First Received: September 2, 2011
Results First Received: July 16, 2016
Last Updated: September 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Boston Scientific Corporation:
peripheral artery disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on October 21, 2016