Clinical trial NCT01436435: The Jetstream (JET) Post-market Registry
Official title: Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Diseases
Keywords: PAD
peripheral artery disease
atherectomy
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-09-19
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Binary Restenosis
timeFrame: 12 months
Secondary outcomes:
measure: Procedural Success
timeFrame: Index Procedure
measure: Ankle-Brachial Index (ABI)
timeFrame: 30 days
measure: Ankle-Brachial Index (ABI)
timeFrame: 6 months
measure: Ankle-Brachial Index (ABI)
timeFrame: 12 months
measure: Major Adverse Events (MAE)
timeFrame: 30 days
Other outcomes:
Locations:
city: Washington DC
country: United States
facility: Nelson Bernardo MD
state: District of Columbia
city: Miami
country: United States
facility: Robert Beasley, MD
state: Florida
city: Davenport
country: United States
facility: Nicolas Shammas, MD
state: Iowa
city: Boston
country: United States
facility: Lawrence Garcia, MD
state: Massachusetts
city: Laurel
country: United States
facility: Vinay Kumar
state: Mississippi
city: Flemington
country: United States
facility: Andrey Espinoza, MD
state: New Jersey
city: Huntington
country: United States
facility: Sotir Polena, MD
state: New York
city: Harrisburg
country: United States
facility: Rajesh Dave, MD
state: Pennsylvania
city: West Reading
country: United States
facility: Ali Amin, MD
state: Pennsylvania
city: Columbia
country: United States
facility: Lee Butterfield, MD
state: South Carolina
city: Kingsport
country: United States
facility: Chris Metzger, MD
state: Tennessee
Study officials:
affiliation: Columbia University
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
References: