Ischemia, MyocardialSORT OUT XIINCT06692140
Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated With Percutaneous Coronary Intervention
A study testing Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s) and PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s)) in people with Ischemia, Myocardial and Coronary Artery Disease, run by Odense University Hospital at 3 sites in Denmark.
Trial summary
The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia, Myocardial, Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s) and PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,150 participants
- Where
- 3 sitesDenmark
- Study dates
- 16 Nov 2024to 1 Jul 2032
- Phase
- Interventional
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
Who may be able to join
- All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents
Who cannot join
- Age < 18 years
- Not able to consent to study participating (eg. intubated patients)
- Unstable circuit or in cardiogenic shock and therefore not able to understand the information and purpose of the study
- Do not speak Danish
- Already included in the SORT OUT XII study
- Life expectancy <1 year
- Allergic to study related treatment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Ashkan Eftekhari, MD, +4597660000, asef@rn.dk
Ashkan Eftekhari, MD
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Evald H Christiansen, MD, +4578450000, evald.christiansen@rm.dk
Evald H Christiansen, MD
- Recruiting
Odense University Hospital
Odense, 5000
Lisette O Jensen, MD, +4565412620, lisette.okkels.jensen@rsyd.dk
Lisette O Jensen, MD
About this study
Official title: Randomized Comparison of an Ultra-low Strut Thickness Everolimus-eluting Biodegradable Polymer Stent Versus Durable Polymer Everolimus-eluting Stents in Patients Treated With Percutaneous Coronary Intervention in an All Comer Population (The SORT OUT XII Trial)
The objective of this randomized study is to compare the safety and efficacy of the ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent to the everolimus-eluting family stents (durable polymer everolimus-eluting Xience or Promus stents) in a population-based setting with coronary artery stenosis treated with percutaneous coronary intervention
- Being tested
- Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s), PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
- Keywords
- Drug-eluting stent, outcome
- Medical subject headings
- Myocardial Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)Device
Percutaneous coronary intervention with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s)
PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))Device
Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s))
| Study group | Role | What they receive |
|---|---|---|
| Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent | Experimental | Percutaneous coronary interventin with Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent Receives: Device: Ultra-low strut thickness everolimus-eluting biodegradable polymer Evermine50 stent(s) |
| Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent) | Active comparator | Percutaneous coronary intervention with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent) Receives: Device: PCI with Everolimus-eluting stents (durable polymer everolimus-eluting Xience or Promus stent(s)) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with target lesion failure
Target lesion failure (TLF) is a composite of cardiac death, myocardial infarction (not clearly attributable to a non-intervention lesion) or target lesion revascularization with percutaneous coronary intervention or coronary artery bypass operation
Measured: 1 year
Secondary outcomes (7)
Number of patients with all-cause death
All-cause death is defined as any death
Measured: 1 year, 3 years and 5 years
Number of patients with cardiac death
Cardiac death is defined as death resulting from cardiovascular causes: death caused by acute myocardial infarction, death caused by sudden cardiac, including unwitnessed, death, death resulting from heart failure, death caused by cardiovascular procedures. Undetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents. Such deaths will be classified as cardiovascular for end point determination
Measured: 1 year, 3 years and 5 years
Number of patients with myocardial infarction
Myocardial infarction diagnosis follows "The Joint ESC/ACCF/AHA/WHF Task Force on "Third Universal Definition of acute myocardial infarction",which has been adapted by Academy Research Consortium. Acute myocardial infarction not related to other than index lesion is defined as any acute myocardial infarction that is not clearly attributable to a non-target vessel
Measured: 1 year, 3 years and 5 years
Number of patients with definite stent thrombosis
Definite stent thrombosis is defined as:
Angiographic confirmation of stent thrombosis. The presence of a thrombus that originates in the stent or in the segment 5 mm proximal or distal to the stent or in a side branch originating from the stented segment and the presence of at least one of the following criteria:
Acute onset of ischemic symptoms at rest New electrocardiographic changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers (refer to definition of spontaneous myocardial infarction) Or Pathological confirmation of stent thrombosis
Measured: 1 year, 3 years and 5 years
Number of patients with probable stent thrombosis
Probable stent thrombosis is defined as any myocardial infarction that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause regardless of the time after the index procedure,
Measured: 1 year, 3 years and 5 years
Number of patients with target lesion revascularization
Target lesion revascularization is defined as a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment including the 5-mm margin proximal and distal to the stent
Measured: 1 year, 3 years and 5 years
Number of patients with target vessel revascularization
Target vessel revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. The target vessel is defined as the entire major intervened coronary vessel, including side branches
Measured: 1 year, 3 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start16 Nov 2024
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia, MyocardialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisette O Jensen, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692140
- Sponsor's protocol ID
- SORT OUT XII STENT
- Other IDs
- VMK2401000
- Acronym
- SORT OUT XII
- Status last verified
- Oct 2026
- First submitted
- 12 Nov 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD used in the results publication