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

Primary Purpose

Peripheral Arterial Diseases

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Jetstream Atherectomy System
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Diseases focused on measuring PAD, peripheral artery disease, atherectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nelson Bernardo MD
  • Robert Beasley, MD
  • Nicolas Shammas, MD
  • Lawrence Garcia, MD
  • Vinay Kumar
  • Andrey Espinoza, MD
  • Sotir Polena, MD
  • Rajesh Dave, MD
  • Ali Amin, MD
  • Lee Butterfield, MD
  • Chris Metzger, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Jetstream Atherectomy System

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Procedural Success
Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
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.
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.
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.
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

Full Information

First Posted
September 2, 2011
Last Updated
September 3, 2016
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01436435
Brief Title
The Jetstream (JET) Post-market Registry
Acronym
JET
Official Title
Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Diseases
Keywords
PAD, peripheral artery disease, atherectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
241 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Jetstream Atherectomy System
Arm Type
Experimental
Arm Description
Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.
Intervention Type
Device
Intervention Name(s)
Jetstream Atherectomy System
Intervention Description
Atherectomy
Primary Outcome Measure Information:
Title
Binary Restenosis
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Procedural Success
Description
Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
Time Frame
Index Procedure
Title
Ankle-Brachial Index (ABI)
Description
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.
Time Frame
30 days
Title
Ankle-Brachial Index (ABI)
Description
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.
Time Frame
6 months
Title
Ankle-Brachial Index (ABI)
Description
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.
Time Frame
12 months
Title
Major Adverse Events (MAE)
Description
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
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Gray, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nelson Bernardo MD
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Robert Beasley, MD
City
Miami
State/Province
Florida
ZIP/Postal Code
33141
Country
United States
Facility Name
Nicolas Shammas, MD
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Lawrence Garcia, MD
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Vinay Kumar
City
Laurel
State/Province
Mississippi
ZIP/Postal Code
39440
Country
United States
Facility Name
Andrey Espinoza, MD
City
Flemington
State/Province
New Jersey
ZIP/Postal Code
08822
Country
United States
Facility Name
Sotir Polena, MD
City
Huntington
State/Province
New York
ZIP/Postal Code
11734
Country
United States
Facility Name
Rajesh Dave, MD
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
Ali Amin, MD
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Lee Butterfield, MD
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Chris Metzger, MD
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Jetstream (JET) Post-market Registry

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