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NCT number NCT02922088
Study type Observational [Patient Registry]
Source Somahlution LLC
Contact Vilas Satishchandran
Phone 215-896-3393
Email vilas.satishchandran@somahlution.com
Status Recruiting
Phase N/A
Start date September 2016
Completion date December 2021

Clinical Trial Summary

The DuraGraft® Registry is a European registry of patients who have undergone CABG and whose vascular grafts have been treated with DuraGraft. All participating sites will be from countries in Europe. The DuraGraft Registry will collect pre-CABG, intraoperative and post-operative data, major post-CABG cardiovascular adverse events, health economic outcomes and patient reported quality of life over a period of 5 years.


Clinical Trial Description

Objectives:

(i) To evaluate the Safety and Performance of DuraGraft®

(ii) To characterize the use of DuraGraft and the outcomes of patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iii) To further characterize the incidence of MACCE outcomes associated with CABG in patients whose vascular grafts were treated with DuraGraft in daily clinical routine

(iv) To compare the use of DuraGraft among hospitals and practices

(v) To obtain patient reported quality of life information

(vi) To obtain important health economics outcomes


Study Design


Related Conditions & MeSH terms


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