The scope of the JET registry to observe long term treatment effects of Jetstream Navitus on various lesions types/morphologies.
* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
241
Atherectomy
Nelson Bernardo MD
Washington D.C., District of Columbia, United States
Robert Beasley, MD
Miami, Florida, United States
Nicolas Shammas, MD
Davenport, Iowa, United States
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.
Time frame: 12 months
Procedural Success
Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
Time frame: Index Procedure
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.
Time frame: 30 days
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.
Time frame: 6 months
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.
Time frame: 12 months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lawrence Garcia, MD
Boston, Massachusetts, United States
Vinay Kumar
Laurel, Mississippi, United States
Andrey Espinoza, MD
Flemington, New Jersey, United States
Sotir Polena, MD
Huntington, New York, United States
Rajesh Dave, MD
Harrisburg, Pennsylvania, United States
Ali Amin, MD
West Reading, Pennsylvania, United States
Lee Butterfield, MD
Columbia, South Carolina, United States
...and 1 more locations
Time frame: 30 days