Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-01-01 @ 9:00 AM
Study NCT ID:
NCT01436435
Status:
COMPLETED
Last Update Posted:
2016-10-19
First Post:
2011-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Jetstream (JET) Post-market Registry
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Jetstream NAVITUS™ System Endovascular Therapy Post-market Registry (JET)
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JET
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.
* To assess and quantify vessel patency 1 year post atherectomy treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: