The Jetstream (JET) Post-market Registry

Completed · Phase 4

Conditions studied: Peripheral Arterial Diseases

In brief

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

Key facts

Study ID

NCT01436435

Run by

Boston Scientific Corporation

People needed

241

Starts

2011-09-01

Expected to finish

2016-02-01

Last updated by the study team

2016-10-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Chris Metzger, MD — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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