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

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

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Diseases
• Intervention / Treatment: 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.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Atherectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binary Restenosis	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy	Index Procedure
Ankle-Brachial Index (ABI)	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.	30 days
Ankle-Brachial Index (ABI)	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.	6 months
Ankle-Brachial Index (ABI)	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.	12 months
Major Adverse Events (MAE)	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	30 days

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): February 1, 2016

Study Registration Dates

• First Submitted: September 2, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (ESTIMATE): September 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 19, 2016
• Last Update Submitted That Met QC Criteria: September 3, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: PAD; atherectomy; peripheral artery disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: D1465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO