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

Foundation of Cardiovascular Research and Education Enschede

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Coronary Restenosis; Acute Coronary Syndrome; Angina Pectoris; Angina, Unstable; Myocardial Infarction; Coronary Stenosis

Treatments: Device: Percutaneous coronary intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04475380

COASTLINE

Details and patient eligibility

About

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.

Enrollment: 1,757 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >18 years
• requiring PCI and treated with Xience Sierra
• capable of providing informed consent

Exclusion criteria

• known intolerance to components of the study DES or antithrombotic/anticoagulant therapy
• planned elective surgery necessitating interruption of dual antiplatelet therapy (DAPT) < 3 months
• patient is known to be pregnant, unlikely to adhere to follow-up or expected live < 1 year

Trial design

1,757 participants in 1 patient group

All-comer patients requiring PCI

Description:

All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES

Treatment:

Device: Percutaneous coronary intervention