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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01436435
Other study ID # D1465
Secondary ID
Status Completed
Phase Phase 4
First received September 2, 2011
Last updated February 10, 2016
Start date September 2011
Est. completion date February 2016

Study information

Verified date February 2016
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


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Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
Jetstream Atherectomy System
Atherectomy

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Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Binary restenosis at 12 months as defined by duplex ultrasound. 12 months No
Secondary Procedural success • Procedural success as defined by successful revascularization of target vessel defined as = 30% residual diameter stenosis following atherectomy +/- adjunctive therapy Through 12 months No
Secondary Improvement in ABI compared to baseline through 12 months No
Secondary Major Adverse Events, as defined by amputation, death, TLR, TVR, MI or angiographic distal embolization that requires a separate intervention or hospitalization. through 12 months No
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