Heart Disease Trial, Recruiting

Written by an AI model from the 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 are at least 18 years old
• People (or their legal guardian) who understand what the trial involves and agree to take part in writing before any trial-related tests or treatment begin
• People who need a procedure to open a blocked coronary artery (called PCI) because a previously placed stent has become narrowed again (known as in-stent restenosis)
• People who have had other non-target artery blockages treated with approved devices before the main trial procedure begins
• People whose narrowed stent area is in a drug-coated stent (single or multiple stent layers are both eligible)
• People whose target blockage is narrowed by at least 50% but not fully blocked, and who have symptoms; or narrowed by at least 70%, or where special pressure measurements show reduced blood flow, even without symptoms
• People whose target blockage was successfully prepared during the procedure (less than 30% narrowing remaining, no serious complications, and no plan to place another stent)
• People whose target blockage is in a natural coronary artery (not a bypass graft)
• People whose target artery has at least some measurable blood flow
• People whose target artery measures more than 2.0 mm and up to 4.0 mm in diameter (estimated visually)
• People whose target blockage area is no longer than 36.0 mm and can be covered by a single balloon
• People with one target in-stent restenosis area per patient, in one main coronary artery or side branch larger than 2.0 mm
• People who have other blockages in non-target arteries that were successfully treated with approved devices before the main trial procedure

Who may not be able to join:

• People who had a major heart attack (STEMI) within 72 hours before arriving at the treating hospital
• People who had a type of heart attack (NSTEACS) where heart damage markers in the blood have not yet reached their peak level
• People who had a coronary artery procedure (PCI) in the 24 hours before the main trial procedure (not counting treatment of non-target blockages during the same procedure)
• People whose target blockage has already been treated with a drug-coated balloon (DCB) at any time
• People in cardiogenic shock, meaning dangerously low blood pressure or needing medicines or devices to support heart function
• People who are on a breathing machine (intubated)
• People whose heart pumping strength (left ventricular ejection fraction) is known to be below 30%
• People who cannot take a combination of blood-thinning medications (DAPT) for at least one month — for example, due to surgery that cannot be delayed
• People who need long-term blood-thinning tablets and cannot also take a specific type of blood thinner called a P2Y12 inhibitor
• People where groin (femoral) access is planned but significant leg artery disease makes it unsafe to insert the required tube (6F sheath)
• People with a low red blood cell level (haemoglobin below 9 g/dL)
• People with a platelet count that is too low (below 100,000 cells/mm³) or too high (above 700,000 cells/mm³)
• People with a low white blood cell count (below 3,000 cells/mm³)
• People currently being treated for an active infection
• People with significant liver disease
• People with significantly reduced kidney function (eGFR below 30 ml/min by a standard formula)
• People with an active stomach ulcer or active bleeding anywhere in the body
• People who had bleeding requiring medical treatment within the past 8 weeks
• People with a history of a blood clotting disorder or who are likely to refuse blood transfusions
• People who had a stroke within the past 3 months, or who have lasting neurological effects from a previous stroke
• People with a known allergy to the trial device materials or required medications, including: sirolimus or similar drugs, aspirin, clopidogrel, prasugrel, ticagrelor, heparin, bivalirudin, or contrast dye that cannot be safely managed with pre-treatment
• People with other serious health conditions that may make it hard to follow the trial requirements (such as dementia or substance use), or that are likely to reduce life expectancy to less than 24 months (such as cancer, heart failure, serious lung disease, or severe heart valve disease)
• People currently taking part in, or planning to join, another clinical trial that has not yet reached its main results
• People who are pregnant or breastfeeding (women who could become pregnant must have a negative pregnancy test within one week before the procedure)
• Women who plan to become pregnant within 12 months after the procedure
• People who have had an organ transplant or are on a waiting list for one
• People who received chemotherapy within 30 days before the procedure, or who are scheduled to receive chemotherapy at any point after the procedure
• People who are taking immunosuppressive medicines by mouth or through a drip, or who have a known life-limiting immune system or autoimmune condition (inhaled steroids and steroids used to prevent or treat contrast dye reactions are allowed)
• People who have more than one in-stent restenosis area in the target artery that cannot all be treated by a single 40 mm drug-coated balloon
• People whose target blockage is in an area that was previously treated with a bare metal stent (a stent without drug coating)
• People with a significant blockage (more than 50%) in the unprotected left main coronary artery, or who need treatment there
• People needing emergency PCI for a major heart attack (STEMI)
• People whose coronary artery disease is considered more suitable for bypass surgery, based on guidelines and the local heart team's assessment
• People who have another blockage in the target or non-target artery that is likely to need a procedure within 12 months after the main trial procedure
• People whose target area was previously treated with radiation therapy (brachytherapy) or a drug-coated balloon
• People whose target blockage is at a point where an artery splits into two, and the side branch is larger than 2.0 mm, with both branches affected
• People whose target blockage is inside or beyond a bypass graft (arterial or vein graft)
• People whose target blockage contains a large blood clot
• People whose target blockage is heavily calcified (hardened with calcium deposits)
• People whose target blockage is a complete or near-complete long-standing blockage that cannot be adequately prepared — though fully or nearly blocked arteries may be eligible if a wire can pass through and good blood flow is restored by the time of randomisation
• People with widespread artery disease beyond the target blockage that significantly reduces blood flow

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