Global Registry for Endovascular Aortic Treatment (GREAT)

Multiple Pathologies Clinical Trial

— GREAT  

Official title:

'GREAT' Global Registry for Endovascular Aortic Treatment - Outcomes Evaluation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01658787
• Other study ID #: GRT 10-11
• Status: Active, not recruiting
• Start date: December 2010
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective, observational Registry to obtain data on device performance and clinical outcomes.

Description:

This is a prospective observational cohort Registry designed to obtain data on device performance and clinical outcomes of patients treated with Gore Endovascular Aortic products.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4600
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Minimum age required by state regulations
• Indication for aortic endovascular stent graft repair
• Signed informed consent

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Multiple Pathologies

Intervention

Device:
• Endovascular aortic repair
Treatment with Gore Endovascular Aortic Products.

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Brazil	Coris Medicina Avançada	Florianópolis
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	IRCCS Policlinico San Donato	Milano
United States	The University of Chicago Medicine & Biological Sciences	Chicago	Illinois
United States	Baylor Research Institute	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect "real world" data on the incidence of serious device events.		Up to 10 years