The Jetstream (JET) Post-market Registry

NCT01436435 | Completed Phase 4 Results

• 1 other identifier: D1465
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

Peripheral Arterial Diseases

Keywords

PAD; peripheral artery disease; atherectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Procedural Success

  Index Procedure

• Ankle-Brachial Index (ABI)

  30 days

• Ankle-Brachial Index (ABI)

  6 months

• Ankle-Brachial Index (ABI)

  12 months

• Major Adverse Events (MAE)

  30 days

Study Arms (1)

Jetstream Atherectomy System

EXPERIMENTAL

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

Interventions

Jetstream Atherectomy System DEVICE

Atherectomy

Jetstream Atherectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

Nelson Bernardo MD

Washington D.C., District of Columbia, 20010, United States

Location

Robert Beasley, MD

Miami, Florida, 33141, United States

Location

Nicolas Shammas, MD

Davenport, Iowa, 52803, United States

Location

Lawrence Garcia, MD

Boston, Massachusetts, 02135, United States

Location

Vinay Kumar

Laurel, Mississippi, 39440, United States

Location

Andrey Espinoza, MD

Flemington, New Jersey, 08822, United States

Location

Sotir Polena, MD

Huntington, New York, 11734, United States

Location

Rajesh Dave, MD

Harrisburg, Pennsylvania, 17110, United States

Location

Ali Amin, MD

West Reading, Pennsylvania, 19611, United States

Location

Lee Butterfield, MD

Columbia, South Carolina, 29204, United States

Location

Chris Metzger, MD

Kingsport, Tennessee, 37660, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: DeeAnn Tinjum, Clinical Trial Manager
• Organization: Boston Scientific

deeann.tinjum@bsci.com

763-494-1927

Study Officials

• William Gray, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 19, 2016
• Results First Posted: August 26, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)