Stroke Trial, Recruiting NCT05998694 Sponsor: Closed Joint-Stock Company NeoCor Condition: Stroke
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Stroke Trial, Recruiting

NCT05998694
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • The person is willing to give written consent to participate and is able to move around freely, without conditions affecting the bones, joints, or brain that would prevent them from travelling to appointments independently.
  • The person lives in the same city or suburb where the trial is being run, or lives in a rural area but is able to travel to the research centre for visits.
  • The person is aged 60–70 years with a life expectancy of at least 3 years; or is under 60 years old and has a medical reason why blood-thinning medications are not suitable, or carries a higher risk from using them, and has made an informed choice to have a biological (tissue-based) heart valve replacement.
  • The person has a condition affecting the aortic valve only, with no other heart valves involved.
  • This would be the person's first surgical procedure on a heart valve.
  • No additional surgical procedures on the heart or the large artery connected to it (such as bypass surgery, tricuspid valve repair, or aortic surgery) are planned at the same time.
  • The valve procedure is planned in advance and is not being carried out as an emergency or urgent "rescue" operation.
  • There is no active or recent serious heart valve infection (endocarditis) present.
  • Before surgery, the person does not have severely high blood pressure in the lungs (pulmonary arterial pressure above 60 mmHg), is not in the most severe category of heart failure symptoms despite treatment, and does not have very poor heart pumping function (ejection fraction below 30%).

Who may not be able to join:

  • People who have serious long-term physical, neurological, or mental health conditions, or infections that are likely to reduce long-term survival — including coronary artery disease, tuberculosis, HIV, Alzheimer's disease, epilepsy, diabetes requiring insulin, significant kidney disease, chronic lung disease requiring ongoing steroid or bronchodilator treatment, or widespread artery disease affecting the legs, neck arteries, or abdomen.
  • People who have any condition unrelated to their heart problem that is expected to lead to death within less than one year.
  • People who are currently enrolled in another clinical study involving a new medication or medical device.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Alexey Evtushenko, MD,PhD, Research Institute for Complex Problems of Cardiovascular Diseases, Russia

Phone: +7 (3842) 64-33-08

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Closed Joint-Stock Company NeoCor
Registry
ClinicalTrials.gov
Start date
1 June 2021
Est. completion
10 August 2025

Where this trial is recruiting

🇷🇺 Russia

Primary endpoints

1. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the long term (long-term safety and durability); 2. Incidence of Treatment-Emergent Adverse Events, requiring repeated surgical intervention in the short term (short-term safety)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov