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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04475380
• Other study ID #: COASTLINE
• Status: Active, not recruiting
• Start date: September 21, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: August 2023
• Source: Foundation of Cardiovascular Research and Education Enschede
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1757
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Device:
• Percutaneous coronary intervention
PCI for treatment of coronary or bypass graft lesions

Locations

Country	Name	City	State
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Thoraxcentrum Twente	Enschede

Sponsors (2)

Lead Sponsor	Collaborator
Foundation of Cardiovascular Research and Education Enschede	Abbott Medical Devices

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target vessel failure (TVF) at 1-year follow up in complex all-comers	TVF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target vessel revascularization.	1 year
Primary	Target lesion failure (TLF) at 2-year follow up in all-comers	TLF is a composite endpoint consisting of cardiac death, target vessel related myocardial infarction, or clinically driven target lesion revascularization.	2 year
Secondary	TVF at 2 year follow up		2 year
Secondary	Death	any/cardiac/non-cardiac	up to 3 year
Secondary	Myocardial infarction	target vessel related/any/periprocedural	up to 3 year
Secondary	Clinically indicated target vessel revascularization		up to 3 year
Secondary	Clinically indicated target lesion revascularization		up to 3 year