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Completed

NCT Number: NCT04475380

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

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.

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Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Artery Disease Coronary Disease Coronary Restenosis Coronary Stenosis Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thoraxcentrum Twente, Enschede, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous coronary intervention

Device

PCI for treatment of coronary or bypass graft lesions

Primary outcomes

  1. Target vessel failure (TVF) at 1-year follow up in complex all-comers

    Time frame: 1 year

    TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization.

  2. Target lesion failure (TLF) at 2-year follow up in all-comers

    Time frame: 2 year

    TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization.

Secondary outcomes

  1. TVF at 2 year follow up

    Time frame: 2 year

  2. Death

    Time frame: up to 3 year

    any/cardiac/non-cardiac

  3. Myocardial infarction

    Time frame: up to 3 year

    target vessel related/any/periprocedural

  4. Clinically indicated target vessel revascularization

    Time frame: up to 3 year

  5. Clinically indicated target lesion revascularization

    Time frame: up to 3 year

Sponsors and collaborators

Lead sponsor

Foundation of Cardiovascular Research and Education Enschede

Other

Collaborators

  • Abbott Medical Devices

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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