Status:
COMPLETED
The Jetstream (JET) Post-market Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Peripheral Arterial Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT01436435
Start Date
September 1 2011
End Date
February 1 2016
Last Update
October 19 2016
Active Locations (11)
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1
Nelson Bernardo MD
Washington D.C., District of Columbia, United States, 20010
2
Robert Beasley, MD
Miami, Florida, United States, 33141
3
Nicolas Shammas, MD
Davenport, Iowa, United States, 52803
4
Lawrence Garcia, MD
Boston, Massachusetts, United States, 02135