NCT03321032

Second-generation Drug-eluting Stents in Diabetes

Second-generation drUg-elutinG Stents in diAbetes: a Randomized Trial (the SUGAR Trial)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,164 (estimated)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator initiated randomized trial, performed under the auspices of the Spanish Society of Cardiology. It is a multicenter, international, parallel, randomized 1:1 (amphilimus-eluting stents vs zotarolimus-eluting stents) clinical trial performed exclusively in patients with diabetes mellitus. The study has an "all-comers diabetics" design. The primary-endpoint is target lesion failure at 1-year follow-up (non-inferiority design) and the co-primary end-point is target lesion failure at 2-years follow-up (superiority-design).

Conditions

• Coronary Artery Disease
• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Polymer-free amphilimus-eluting stents	Cre8 Evo coronary stent system (CID, Saluggia, Italy)
DEVICE	Biolinx Polymer-based zotarolimus-eluting stents	Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)

Timeline

• Start date: 2017-12-19
• Primary completion: 2021-01-28
• Completion: 2022-01-28
• First posted: 2017-10-25
• Last updated: 2021-01-19

Locations

23 sites across 1 country: Spain