Heart Disease Trial, Completed

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 are at least 18 years old
• People (or their legal guardian) who understand what the study involves and have given written consent before any study-related tests begin
• People under 20 years old enrolling at a site in Japan, where both the patient and their legal representative must provide written consent
• People who are suitable candidates for a heart procedure called percutaneous coronary intervention (PCI), which opens blocked or narrowed arteries using a small tube inserted through the skin
• People who have been diagnosed with stable chest pain (angina), silent reduced blood flow to the heart, or unstable chest pain
• People who would also be considered suitable for open-heart bypass surgery (CABG) if needed
• People whose heart pumping function (measured as left ventricular ejection fraction) is 30% or above, tested within the 30 days before joining
• People who are willing to attend all required follow-up visits as set out in the study plan
• People whose blocked artery meets specific measurement requirements: the blockage must be in a new, untreated section of a coronary artery; the artery must be a certain width (between 2.25 mm and less than 2.5 mm); the blockage must be no longer than 28 mm; the blockage must be between 50% and 99% narrowed; and there must still be some blood flow through the artery (confirm exact measurements with trial site)

Who may not be able to join:

• People who are currently showing signs or test results consistent with an active heart attack
• People who have had a heart attack within the 72 hours before the procedure and still have certain elevated heart enzyme levels in their blood at the time of the procedure (confirm specific enzyme thresholds with trial site)
• People who have received an organ transplant or are currently on a waiting list for one
• People who are receiving or are scheduled to receive chemotherapy within 30 days before or after the procedure
• People who are taking oral or intravenous medicines that suppress the immune system, or who have a serious immune or autoimmune condition such as HIV or lupus (note: inhaled steroids and diabetes are not excluded)
• People who have been taking blood-thinning medication (such as heparin or warfarin) continuously for 72 hours or more for reasons unrelated to a heart condition
• People whose platelet count (a blood clotting measure) is below 100,000 or above 700,000 cells per cubic millimetre
• People whose white blood cell count is below 3,000 cells per cubic millimetre
• People with a known or suspected liver condition, including evidence of hepatitis
• People on dialysis or with significantly reduced kidney function (confirm the specific kidney function threshold with trial site)
• People with a history of abnormal bleeding or blood clotting problems, or who would refuse a blood transfusion if needed
• People who have had a stroke or mini-stroke (TIA) within the past 6 months, or who have a permanent neurological condition that may make it difficult to follow the study requirements
• People whose target artery (the one being treated) has previously been treated with any type of heart procedure such as balloon angioplasty or stenting within the past 12 months
• People whose target artery has ever been treated within 10 mm of the area now being targeted
• People who had a procedure on a different heart artery within the 24 hours before the study procedure
• People for whom certain non-approved devices or techniques are planned to be used on the target artery immediately before the stent is placed (confirm with trial site)
• People who have a further PCI or bypass surgery already planned after the study procedure
• People who have previously had radiation therapy inside a coronary artery (intravascular brachytherapy)
• People with a known allergy to any materials in the study stent or to required study medications (such as aspirin, certain anti-clotting drugs, contrast dye, or the metals used in the stent) that cannot be managed with pre-treatment
• People with an active stomach ulcer or active bleeding in the digestive tract
• People with another serious illness (such as cancer or advanced heart failure) that may mean life expectancy is less than 24 months
• People with current substance abuse problems (such as alcohol, cocaine, or heroin)
• People with a planned procedure that could interfere with following the study or make the results difficult to interpret
• People currently taking part in another clinical trial of an experimental drug or device that has not yet completed its main analysis
• People who plan to join another clinical trial of an experimental drug or device within 12 months after the study procedure
• People who intend to try to conceive a child within 12 months after the procedure (women of childbearing age who are sexually active must agree to use reliable contraception from screening through to 12 months after the procedure)
• Women who are currently pregnant or breastfeeding (a pregnancy test is required within 7 days before the procedure for women who could potentially be pregnant)
• People who have more than 2 blockages being treated, or more than one target blockage and one additional blockage, during the study procedure

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