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NCT04475380Completed

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)

Source: ClinicalTrials.gov · Last updated 6 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
1757 (actual)
First submitted
14 Jul 2020
Start date
21 Sept 2018
Primary completion date
15 Dec 2025
Lead sponsor
Foundation of Cardiovascular Research and Education Enschede
NCT number
NCT04475380

What you commit to

  • Study type: Observational
  • Participants enrolled: 1757
  • From 21 Sept 2018 to the primary completion date, 15 Dec 2025
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • known intolerance to components of the study DES or antithrombotic/anticoagulant therapy
  • planned elective surgery necessitating interruption of dual antiplatelet therapy (DAPT) \< 3 months

Other

  • patient is known to be pregnant, unlikely to adhere to follow-up or expected live \< 1 year

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Thoraxcentrum Twente
Coordinator of this site? Confirm its status
EnschedeNetherlandsUnknown status
Haga Ziekenhuis
Coordinator of this site? Confirm its status
The HagueNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.