Viewing Study NCT01406795


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Study NCT ID: NCT01406795
Status: TERMINATED
Last Update Posted: 2017-02-27
First Post: 2011-07-22
Is NOT Gene Therapy: True
Has Adverse Events: True

Brief Title: The GORE Viabahn Endoprosthesis for the Treatment of Venous Occlusions and Stenoses
Sponsor: Stanford University
Organization:

Study Overview

Official Title: Evaluation of GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface for the Treatment of Venous Occlusions and Stenoses
Status: TERMINATED
Status Verified Date: 2017-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Poor enrollment and advances in venoplasty only techniques of the femoral vein
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: To study the safety and efficacy of drug coated stents for the treatment of venous occlusions and stenoses in the lower extremity. The use of the device for the treatment of peripheral arterial disease is approved by the FDA, however, the use of the device in venous occlusions and stenoses, although performed by some practitioners, has not yet been studied in detail.
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
FDA IDE - G090054 None None View
IRB eProtocol - 14781 None None View
SPO # 49275 None None View