Active — Not RecruitingNot Applicable

The OCT SORT-OUT VIII Study

Denmark160 participantsStarted 2014-05

Plain-language summary

The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients \>18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital Exclusion Criteria: * Age \<18 years * Do not wish to participate * Unable to provide written informed consent * Domicile outside Denmark * Do not speak Danish * Inclusion in the SORT-OUT VIII study * Inclusion in other stent studies * Expected survival \<1 year * Allergy to aspirin, clopidogrel, prasugrel or ticagrelor * Hypersensitivity to everolimus or biolimus * The operator wishes to use other DES * Reduced renal function; creatinine\> 120 mmol / L * Only bare metal stent (BMS) implantation * Only plain old balloon angioplasty (POBA)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Coronary Stent Healing Index

Timeframe: 1 or 3 months

Uncovered stent struts

Timeframe: 1 or 3 months

Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts

Timeframe: 1 and 3 months

Persistent malapposition

Timeframe: 1 and 3 months

Neointimal thickness in one frame or lumen mean diameter stenosis

Timeframe: 1 and 3 months

Acquired malapposition

Timeframe: 1 and 3 months

Cumulated extra stent lumen increase in matched cross sectional analysis

Timeframe: 1 and 3 months

Trial details

NCT IDNCT02253108

SponsorAarhus University Hospital Skejby

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

View on ClinicalTrials.gov More Coronary Artery Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Coronary Stent Healing Index

Timeframe: 1 or 3 months

Uncovered stent struts

Timeframe: 1 or 3 months

Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts

Timeframe: 1 and 3 months

Persistent malapposition

Timeframe: 1 and 3 months

Neointimal thickness in one frame or lumen mean diameter stenosis

Timeframe: 1 and 3 months

Acquired malapposition

Timeframe: 1 and 3 months

Cumulated extra stent lumen increase in matched cross sectional analysis

Timeframe: 1 and 3 months