CompletedNot Applicable

Heterogeneity of Neointimal Healing Following Biodegradable-polymer Drug-Eluting Coronary Stent Implantation

Russia50 participantsStarted 2020-01-13

Plain-language summary

The objective of this study is a comparative evaluation of Orsiro stent and of Resolute Integrity stent in terms of the extent of neointima formation at 4 months after implantation using optical coherence tomography (OCT).

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: * Age \> 18 years; * Patients with symptoms of stable angina and/or presence of a positive functional test for ischemia; * Patient is eligible for percutaneous coronary intervention (PCI); * Patient has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Ethical Committee of the respective clinical site. Exclusion Criteria: * Target lesion involving a bifurcation with a side branch ≥2.0 mm in diameter; * Target lesion located in the left main stem; * Target lesion is located or supplied by an arterial or venous bypass graft; * Lesion located very distally, difficult to be imaged by OCT; * Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; * Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study; * Patient underwent target vessel revascularization with a DES; * Patient presenting with acute myocardial infarction with ST elevation; * Cerebrovascular accident within the past 12 months; * Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl); * Patient receiving oral anticoagulants

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

Heterogeneous neointimal healing

Timeframe: 4 ± 1 months

Trial details

NCT IDNCT04465669

SponsorTomsk National Research Medical Center of the Russian Academy of Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Coronary Heart 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.