Heart Disease Trial, Recruiting
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:
- A legally authorised representative of the patient has been told about the device treatment, agrees to its terms, and has signed a written consent form
- The patient's condition has been assessed as appropriate for treatment with the Minima Stent System according to the device's official instructions for use
Who may not be able to join:
- People who have had an active bloodstream infection requiring antibiotic treatment within the 3 days before the stent procedure
- People who have a history of, or are currently being treated with antibiotics for, a heart valve infection (endocarditis) within the 180 days before the stent procedure
- People who have an abnormal bulging (aneurysm) of the aorta or pulmonary artery in the area being treated
- People who weigh less than 1.5 kilograms
- People whose anatomy in the treatment area is judged by the investigator to make safe stent placement not possible
- People whose blood vessel size falls outside the range that the Minima System balloons are designed to treat
- People with a known genetic condition linked to blood vessel problems, such as Williams syndrome or Loeys-Dietz syndrome, among others
- People whose clinical situation requires more than one blood vessel to receive a stent during the trial procedure
- People who are currently taking part in another investigational drug or medical device study
- People with a serious or worsening non-heart-related illness that means their life expectancy is less than six months
- People with a known allergy to aspirin or heparin where treatment with alternative blood-thinning medications is also not possible
- People with a known allergy to cobalt-chromium (the stent material) or to contrast dye used in imaging, where the allergy cannot be adequately managed beforehand
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.
Contact this trial
Principal Investigator: Arash Salavitabar, MD, Nationwide Children's Hospital
Phone: 855-318-4988
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Rate of Acute Device Success; Rate of Participants with Freedom from procedure- or device-related SAEs
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.