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
- Diseases
- Coronary artery disease
- 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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thoraxcentrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Unknown status |
| Haga Ziekenhuis Coordinator of this site? Confirm its status | The Hague | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.