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 aged 18 to 80 years old
• People who have given written consent to take part before any study-related procedures begin
• People whose condition means a heart procedure (called PCI — where a blocked artery is opened using a small tube and balloon) is considered appropriate according to current medical guidelines
• People who are also considered suitable candidates for open heart bypass surgery if needed
• People diagnosed with stable or unstable chest pain (angina), confirmed reduced blood flow to the heart without symptoms, or a type of heart attack (called NSTEMI) that has not caused major instability, and where there is no sign of a blood clot at the blocked area being treated
• People who have had a different type of heart attack (STEMI) may still be considered, but only for treatment of a blockage in a different artery than the one that caused the heart attack — and only if at least 72 hours have passed since successful treatment of the original blockage, the person is medically stable, and heart damage markers in the blood are falling (confirm with trial site)
• People who are able to take a combination of two blood-thinning medications (called dual antiplatelet therapy, or DAPT) — specifically aspirin plus one of: clopidogrel, prasugrel, ticagrelor, cangrelor, or ticlopidine
• People with a documented heart pumping strength (called ejection fraction) of at least 30%, measured within 6 months before or during the procedure
• People who are willing and able to attend all required study visits and follow all study requirements for the full duration of the trial
• People with no more than two new, previously untreated blockages, each located in a separate heart artery
• People where the target artery being treated measures between 2.7 and 4.2 mm in diameter (as estimated by the treating doctor using imaging tools)
• People where the blockage being treated is longer than 28 mm and no more than 38 mm, and can be treated with a single study device
• People where the blockage narrows the artery by at least 50% but is not completely closed, and where the artery still has at least some blood flowing through it

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study period
• People who have had a major heart attack (STEMI) with symptoms or abnormal heart readings within 72 hours before the procedure
• People who have had a previous heart artery procedure (PCI) in the target artery within the last 12 months, or a procedure in any other heart artery within 72 hours before the planned procedure
• People who are on kidney dialysis or have significantly reduced kidney function (based on a blood test result taken within 72 hours before the procedure)
• People with a known allergy to contrast dye used in imaging that cannot be managed with pre-treatment, or known allergies to aspirin, blood-thinning medications (P2Y12 inhibitors), both heparin and bivalirudin (types of blood thinners), sirolimus or similar drugs, or any of the materials used in the study device (including magnesium, aluminum, or tantalum)
• People currently taking medications that suppress the immune system by mouth or through a drip (inhaled steroids are allowed), or people with certain immune system conditions such as HIV or lupus (diabetes is allowed)
• People whose life expectancy is less than one year
• People who have planned surgery or a dental surgical procedure within 6 months after the procedure, unless the two blood-thinning medications can be safely continued throughout
• People who the treating doctor believes will not be able to attend follow-up visits or meet study requirements
• People taking long-term oral blood-thinning medication (anticoagulants) before the procedure, unless they are able to safely take both anticoagulants and dual antiplatelet therapy together for at least one month
• People who have had a stroke or mini-stroke (TIA) within the 6 months before the procedure
• People with an active bleeding disorder, a blood-clotting problem, or any other condition that makes dual antiplatelet therapy unsuitable
• People who are already participating in, or plan to participate in, another clinical trial involving an experimental device or drug
• People where the target blockage is within 5 mm of a previously treated area in the same artery
• People with disease in the left main coronary artery (the main artery supplying the heart)
• People where the target blockage is completely closed (100% blocked)
• People with a blood clot visible in the target artery
• People who have a further planned heart artery procedure (PCI) scheduled in any artery after this one
• People where the blockage is located at the very opening of certain major heart arteries (within 5 mm of where the artery begins)
• People where the blockage involves a branching artery of 2.0 mm or more in diameter that would require two devices to treat after initial balloon preparation
• People where the blockage is in or supplied by a bypass graft (from a previous bypass surgery)
• People where the artery leading to the blockage is very twisted, or the blockage itself is very heavily calcified and cannot be adequately prepared with standard balloon techniques
• People where the blockage requires special preparation tools beyond standard balloons (such as atherectomy devices, lithotripsy, or drug-coated balloons) before the study device can be placed
• People whose target artery was previously treated with radiation therapy (brachytherapy) at any time
• People where the initial balloon preparation of the blockage was not successful, meaning significant narrowing or complications remain

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