The Jetstream (JET) Post-market Registry

Peripheral Arterial Diseases Clinical Trial

— JET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436435
• Other study ID #: D1465
• Status: Completed
• Phase: Phase 4
• First received: September 2, 2011
• Last updated: February 10, 2016
• Start date: September 2011
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is = 18 years of age.

• The target de novo or restenotic 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases

Intervention

Device:
• Jetstream Atherectomy System
Atherectomy

Locations

Country	Name	City	State
United States	Lawrence Garcia, MD	Boston	Massachusetts
United States	Lee Butterfield, MD	Columbia	South Carolina
United States	Nicolas Shammas, MD	Davenport	Iowa
United States	Andrey Espinoza, MD	Flemington	New Jersey
United States	Rajesh Dave, MD	Harrisburg	Pennsylvania
United States	Sotir Polena, MD	Huntington	New York
United States	Chris Metzger, MD	Kingsport	Tennessee
United States	Vinay Kumar	Laurel	Mississippi
United States	Robert Beasley, MD	Miami	Florida
United States	Nelson Bernardo MD	Washington DC	District of Columbia
United States	Ali Amin, MD	West Reading	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary restenosis at 12 months as defined by duplex ultrasound.		12 months	No
Secondary	Procedural success	• Procedural success as defined by successful revascularization of target vessel defined as = 30% residual diameter stenosis following atherectomy +/- adjunctive therapy	Through 12 months	No
Secondary	Improvement in ABI compared to baseline		through 12 months	No
Secondary	Major Adverse Events, as defined by amputation, death, TLR, TVR, MI or angiographic distal embolization that requires a separate intervention or hospitalization.		through 12 months	No