The Jetstream (JET) Post-market Registry

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Diseases

Treatments: Device: Jetstream Atherectomy System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01436435

D1465

Details and patient eligibility

About

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

Full 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.

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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241 participants in 1 patient group

Jetstream Atherectomy System

Experimental group

Description:

Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.

Treatment:

Device: Jetstream Atherectomy System