Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with either a recent (acute) or ongoing (chronic) heart artery problem (coronary syndrome)
• People who have been diagnosed with diabetes
• People who are having a procedure called PCI (a treatment to open blocked heart arteries) on a new blockage in a natural heart artery (not a previously treated one)
• People who are willing and able to sign a consent form agreeing to take part
• People aged 18 years or older
• People who are willing and able to attend all required study visits and follow-up appointments
• People whose blocked artery meets specific technical requirements during the procedure — including that the blockage has been assessed as treatable, a guidewire has been passed through it, and a preparatory balloon treatment has been completed successfully with less than 50% narrowing remaining and adequate blood flow restored (confirm with trial site)

Who may not be able to join:

• People whose blockage is located in a specific part of the heart artery called the left main coronary artery
• People who are currently having a major heart attack (called a STEMI)
• People who are experiencing severe acute heart failure or cardiogenic shock (when the heart suddenly cannot pump enough blood)
• People whose kidneys are not working well enough (as measured by a specific blood filtration rate below 30 mL/min/1.73 m²) (confirm with trial site)
• People with severe calcium build-up inside a previously placed stent that would prevent the treatment balloon from expanding properly, unless that calcium has already been adequately treated beforehand
• People who show signs of a significant tear in the artery wall (classified as a high-grade dissection) at the start of the procedure
• People with a known allergy or medical reason they cannot take certain medications used in the trial — including sirolimus, paclitaxel, heparin, aspirin, thienopyridines, or iodinated contrast dye — where that allergy cannot be managed with pre-treatment
• People who are unable to take a combination of two blood-thinning medications (dual antiplatelet therapy) for 6 to 12 months
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period
• People who are currently taking part in another clinical trial where the main results have not yet been collected
• People for whom completing a follow-up heart imaging scan (angiographic surveillance) may be difficult
• People with a life expectancy of less than 12 months
• People who, due to a condition such as dementia, are not able to provide informed consent
• People who, in the opinion of the trial investigator, do not have a sufficient understanding of English to fully understand what participation in the study involves

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