NCT04475380

Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents

Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,757 (actual)
• Sponsor: Foundation of Cardiovascular Research and Education Enschede · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Drug eluting stents (DES) are widely used for treatment of coronary artery lesions. The Xience Sierra stent has a refined design of the metal stent backbone and is used in patients with various clinical syndromes and in different lesions. Clinical outcome of patients with previously unknown (silent) diabetes and prediabetes is of increasing interest since the latter group has recently shown to be associated with a significant risk of adverse cardiovascular events after treatment with contemporary DES. Outcome data in a population of high-risk all-comer patients, including many patients with diabetes mellitus and prediabetes, would be of great interest, but such data are not available yet. In addition, there is a lack of data in a general all-comer population. Therefore, the COASTLINE study will primarily assess the safety and efficacy of the Xience Sierra stent in a general all-comer population as well as a high-risk all-comer population.

Conditions

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Myocardial Infarction
• Coronary Artery Disease
• Coronary Stenosis
• Coronary Restenosis

Interventions

Type	Name	Description
DEVICE	Percutaneous coronary intervention	PCI for treatment of coronary or bypass graft lesions

Timeline

• Start date: 2018-09-21
• Primary completion: 2025-12-15
• Completion: 2025-12-31
• First posted: 2020-07-17
• Last updated: 2026-02-06

Locations

2 sites across 1 country: Netherlands

Regulatory

• FDA-regulated device study