Acute Coronary SyndromeNCT04475380
Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents
An observational study of Acute Coronary Syndrome and Angina Pectoris, run by Foundation of Cardiovascular Research and Education Enschede at 2 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 1,757 participants
- Where
- 2 sitesNetherlands
- Study dates
- 21 Sep 2018to 31 Dec 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers. Patients for elective PCI or acute PCI
Who may be able to join
- >18 years
- requiring PCI and treated with Xience Sierra
- capable of providing informed consent
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)
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.
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis
- Being tested
- Percutaneous coronary intervention
- Keywords
- Drug-eluting stent, Durable polymer, Everolimus, All comers population, High-risk all comers, Target vessel failure, Coronary artery disease
- Medical subject headings
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis, Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
PCI for treatment of coronary or bypass graft lesions
| Study group | Role | What they receive |
|---|---|---|
| All-comer patients requiring PCI | All-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
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.
Measured: 2 year
Secondary outcomes (5)
TVF at 2 year follow up
Measured: 2 year
Death
any/cardiac/non-cardiac
Measured: up to 3 year
Myocardial infarction
target vessel related/any/periprocedural
Measured: up to 3 year
Clinically indicated target vessel revascularization
Measured: up to 3 year
Clinically indicated target lesion revascularization
Measured: up to 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start21 Sep 2018
- Primary completion15 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,757 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Foundation of Cardiovascular Research and Education Enschede
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475380
- Sponsor's protocol ID
- COASTLINE
- Status last verified
- Feb 2026
- First submitted
- 14 Jul 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Anthonio RL, Zocca P, Hartmann M, Stoel MG, de Man FHAF, Linssen GCM, Doggen CJM, van der Heijden LC, Kok MM, von Birgelen C. Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk. Eur Heart J Open. 2025 Oct 21;5(6):oeaf140. doi: 10.1093/ehjopen/oeaf140. eCollection 2025 Nov.
PubMed 41230396
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex All-comers and Patients With Diabetes or Prediabetes, Treated With Xience Sierra Everolimus-eluting Stents (COASTLINE)
- ClinicalTrials.gov ID
- NCT04475380
- Acronym / sponsor ID
- COASTLINE
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Angina, Unstable, Myocardial Infarction, Coronary Artery Disease, Coronary Stenosis
- Keywords
- Drug-eluting stent, Durable polymer, Everolimus, All comers population, High-risk all comers, Target vessel failure, Coronary artery disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,757 participants (actual)
- Lead sponsor
- Foundation of Cardiovascular Research and Education EnschedeUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All-comer patients requiring PCI | – | Device: Percutaneous coronary interventionAll-comer patients requiring percutaneous coronary intervention (PCI) for the treatment of significant coronary artery of bypass graft lesions that are suitable for treatment with Xience Sierra DES |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers. Patients for elective PCI or acute PCI
Key inclusion criteria (3 listed)
- >18 years
- requiring PCI and treated with Xience Sierra
- capable of providing informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionPCI for treatment of coronary or bypass graft lesions | Device | All-comer patients requiring PCI |
Primary outcome
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.
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.
5 secondary outcomes
TVF at 2 year follow up
Time frame: 2 year
Death
Time frame: up to 3 year
Myocardial infarction
Time frame: up to 3 year
Clinically indicated target vessel revascularization
Time frame: up to 3 year
Clinically indicated target lesion revascularization
Time frame: up to 3 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 41230396van Vliet D, Ploumen EH, Pinxterhuis TH, Buiten RA, Aminian A, Schotborgh CE, Anthonio RL, Zocca P, Hartmann M, Stoel MG, de Man FHAF, Linssen GCM, Doggen CJM, van der Heijden LC, Kok MM, von Birgelen C. Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk. Eur Heart J Open. 2025 Oct 21;5(6):oeaf140. doi: 10.1093/ehjopen/oeaf140. eCollection 2025 Nov.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Angina Pectoris, run by Foundation of Cardiovascular Research and Education Enschede at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF) at 1-year follow up in complex all-comers (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04475380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.