The Jetstream (JET) Post-market Registry (JET)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01436435|
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : August 26, 2016
Last Update Posted : October 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Diseases||Device: Jetstream Atherectomy System||Phase 4|
- 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 (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Jetstream Atherectomy System
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
- Binary Restenosis [ Time Frame: 12 months ]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.
- Procedural Success [ Time Frame: Index Procedure ]Percentage of patients with successful revascularization of target vessel defined as ≤ 30% residual diameter stenosis following atherectomy +/- adjunctive therapy
- Ankle-Brachial Index (ABI) [ Time Frame: 30 days ]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.
- Ankle-Brachial Index (ABI) [ Time Frame: 6 months ]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.
- Ankle-Brachial Index (ABI) [ Time Frame: 12 months ]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.
- Major Adverse Events (MAE) [ Time Frame: 30 days ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436435
|United States, District of Columbia|
|Nelson Bernardo MD|
|Washington DC, District of Columbia, United States, 20010|
|United States, Florida|
|Robert Beasley, MD|
|Miami, Florida, United States, 33141|
|United States, Iowa|
|Nicolas Shammas, MD|
|Davenport, Iowa, United States, 52803|
|United States, Massachusetts|
|Lawrence Garcia, MD|
|Boston, Massachusetts, United States, 02135|
|United States, Mississippi|
|Laurel, Mississippi, United States, 39440|
|United States, New Jersey|
|Andrey Espinoza, MD|
|Flemington, New Jersey, United States, 08822|
|United States, New York|
|Sotir Polena, MD|
|Huntington, New York, United States, 11734|
|United States, Pennsylvania|
|Rajesh Dave, MD|
|Harrisburg, Pennsylvania, United States, 17110|
|Ali Amin, MD|
|West Reading, Pennsylvania, United States, 19611|
|United States, South Carolina|
|Lee Butterfield, MD|
|Columbia, South Carolina, United States, 29204|
|United States, Tennessee|
|Chris Metzger, MD|
|Kingsport, Tennessee, United States, 37660|
|Principal Investigator:||William Gray, MD||Columbia University|