The Jetstream (JET) Post-market Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by MEDRAD, Inc.
Sponsor:
Information provided by (Responsible Party):
MEDRAD, Inc.
ClinicalTrials.gov Identifier:
NCT01436435
First received: September 2, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Peripheral Arterial Diseases
Device: Jetstream Navitus
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)

Resource links provided by NLM:


Further study details as provided by MEDRAD, Inc.:

Primary Outcome Measures:
  • Binary restenosis at 12 months as defined by duplex ultrasound. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Procedural success [ Time Frame: Through 12 months ] [ Designated as safety issue: No ]
    • Procedural success as defined by successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy

  • Improvement in ABI compared to baseline [ Time Frame: through 12 months ] [ Designated as safety issue: No ]
  • Major Adverse Eventss, defined by amputation, death, TLR, TVR, MI or angiographic distal embolization that requires a separate intervention or hospitalization. [ Time Frame: through 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2011
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Jetsteram Navitus
Atherectomy
Device: Jetstream Navitus
Atherectomy
Other Name: Atherectomy

Detailed Description:
  • To observe the treatment effects of the Pathway Medical 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436435

Contacts
Contact: Susanna Kennedy 7634508021 susanna.kennedy@bayer.com

Locations
United States, District of Columbia
Nelson Bernardo MD Recruiting
Washington DC, District of Columbia, United States, 20010
United States, Florida
Robert Beasley, MD Recruiting
Miami, Florida, United States, 33141
United States, Iowa
Nicolas Shammas, MD Recruiting
Davenport, Iowa, United States, 52803
United States, Massachusetts
Lawrence Garcia, MD Recruiting
Boston, Massachusetts, United States, 02135
United States, Mississippi
Vinay Kumar Terminated
Laurel, Mississippi, United States, 39440
United States, New Jersey
Andrey Espinoza, MD Recruiting
Flemington, New Jersey, United States, 08822
United States, New York
Sotir Polena, MD Not yet recruiting
Huntington, New York, United States, 11734
United States, Ohio
Gary Fishbein, MD Withdrawn
Dayton, Ohio, United States, 45406
United States, Pennsylvania
Rajesh Dave, MD Recruiting
Harrisburg, Pennsylvania, United States, 17110
Ali Amin, MD Recruiting
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Lee Butterfield, MD Recruiting
Columbia, South Carolina, United States, 29204
United States, Tennessee
Chris Metzger, MD Recruiting
Kingsport, Tennessee, United States, 37660
Sponsors and Collaborators
MEDRAD, Inc.
Investigators
Principal Investigator: William Gray, MD Columbia University
  More Information

No publications provided

Responsible Party: MEDRAD, Inc.
ClinicalTrials.gov Identifier: NCT01436435     History of Changes
Other Study ID Numbers: D1465
Study First Received: September 2, 2011
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MEDRAD, Inc.:
PAD
peripheral artery disease
atherectomy

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014