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

  • STATUS
    Recruiting
  • participants needed
    1757
  • sponsor
    Foundation of Cardiovascular Research and Education Enschede
Updated on 19 February 2024
diabetes
clinical syndrome
stenosis
everolimus
myocardial infarction
infarct
acute coronary syndrome
percutaneous coronary intervention
unstable angina
angina pectoris
coronary artery stenosis
glucose intolerance
clinical syndromes
prediabetes

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.

Details
Condition Coronary Restenosis, Chest Pain, Chest Pain, Coronary Artery Disease, Coronary Artery Disease, Coronary heart disease, Myocardial Infarction, Acute Coronary Syndrome, Coronary Artery Stenosis, Angina Pectoris, Unstable angina, Ischemic Heart Disease
Age 18-100 years
Treatment Percutaneous coronary intervention
Clinical Study IdentifierNCT04475380
SponsorFoundation of Cardiovascular Research and Education Enschede
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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