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:

• Adults aged 18 or older
• People who have been diagnosed with stable chest pain (chronic stable angina) or a recent heart event that has since been stabilised, with heart enzyme blood test results back within normal range
• People who have at least one new (previously untreated) narrowing in a small heart artery — specifically one that is wider than 2.00 mm and no wider than 3.00 mm, with the artery narrowed between 50% and 99% — noting that having a previously placed stent in the same general area of the heart does not automatically exclude participation
• People whose artery narrowing is planned to be treated with a drug-coated balloon (DCB) of either less than 30 mm in length, or 30 mm or longer in length
• People who are able to understand and agree to the study requirements, including a follow-up heart scan (angiogram) at 12 months
• People who have already completed all follow-up requirements from any previous clinical study they were part of

Who may not be able to join:

• Women who are pregnant or currently breastfeeding, or women of childbearing age whose pregnancy test (taken within 7 days before the procedure) returns a positive result
• People who are currently experiencing an active heart attack, as shown by ECG results or blood test markers that have not yet returned to normal
• People with a known allergy or medical reason to avoid sirolimus, paclitaxel, aspirin, heparin, or all four of the following blood-thinning medications together: clopidogrel, ticlopidine, prasugrel, and ticagrelor
• People who have had a previous procedure using a drug-coated balloon in the same area of the heart within the last 12 months
• People who have had a stroke or mini-stroke (TIA) within the last 6 months
• People whose heart pumping function is significantly reduced (specifically, a left ventricular ejection fraction below 30%)
• People with abnormal blood cell counts or known or suspected liver disease, including hepatitis (confirm specific values with trial site)
• People with significant kidney problems, including those on dialysis or experiencing acute kidney failure (confirm specific threshold values with trial site)
• People who have planned surgery within the next month that would require stopping their dual blood-thinning medication
• People with a history of abnormal bleeding or blood clotting disorders
• People who have received a heart transplant
• People with another medical condition that means life expectancy is less than 12 months
• People who are unable or unwilling to return for a follow-up heart scan (angiogram) at 12 months
• People who are currently participating in another clinical trial
• People whose target artery is larger than 3.00 mm or 2.00 mm or smaller
• People whose artery narrowing is less than 50% before balloon preparation
• People whose artery is completely blocked, or where blood flow is very poor (TIMI flow below 2) before balloon preparation
• People in whom the preparatory balloon procedure was not performed or did not succeed (confirm specific criteria with trial site)
• People where the narrowing is located in the left main stem — the main artery supplying the left side of the heart
• People where a blood clot is visible in the target artery
• People where the narrowing is located at the point where the artery joins the main large vessel of the body (the aorta), within 3 mm of that junction
• People where the narrowing is inside or beyond a bypass graft (either artery or vein graft)

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