The Jetstream (JET) Post-market Registry

NCT ID: NCT01436435

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2016-02-29

Brief 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.

Conditions

Peripheral Arterial Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jetstream Atherectomy System

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

Group Type: EXPERIMENTAL

Jetstream Atherectomy System

Intervention Type: DEVICE

Atherectomy

Interventions

Jetstream Atherectomy System

Atherectomy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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

Countries

United States

Other Identifiers

D1465

Identifier Type: -

Identifier Source: org_study_id