The outcome of a new vascular stent in patients with arterial disease in the legs

Not Applicable

Withdrawn

• Conditions: Femoro-popliteal Arterial Disease; Peripheral Arterial Diseaes; Chronic Limb Ischaemia; Critical Limb Ischaemia; Claudication; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12618001310257
• Lead Sponsor: Dr. Vikram Puttaswamy (Investigator)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-06
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Aged 18 years or above
Patients with arterial disease from the SFA origin to the popliteal bifurcation scheduled to be treated or have been treated with the TIGRIS GORE stent
De novo lesions and post-angioplasty stenoses
All lesion lengths suitable for a TIGRIS GORE stent

Exclusion Criteria

Lesions with in-stent restenosis
Patients contraindicated to having dual antiplatelet or anticoagulation therapy including a history of heparin induced thrombocytopenia and thrombosis (HITTS)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary patency via duplex ultrasound[3, 6, 9, 12, 24 and 36 months]

Secondary Outcome Measures

Name	Time	Method
Primary assisted patency via US duplex<br>[3, 6, 9, 12, 24 and 36 months];Secondary patency via duplex ultrasound<br>[3, 6, 9, 12, 24 and 36 months];Rate of stent fracture via X-ray[3, 6, 9, 12. 18 and 24 months]