Phase 3 Heart Disease Trial, Completed

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 study involves and agree in writing before any study tests begin
• People being enrolled at a Japanese site who are under 20 years old must have both their own written consent and their legal representative's written consent
• People who are suitable candidates for a procedure called percutaneous coronary intervention (PCI), a procedure to open blocked heart arteries (confirm with trial site)
• People who have documented stable chest pain, silent lack of 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 strength (left ventricular ejection fraction) has been measured at 30% or above within the 30 days before joining the trial
• People who are willing to attend all required follow-up appointments during the trial
• People whose blocked artery meets specific measurement criteria: the blockage in a native (non-grafted) coronary artery must be a new (not previously treated) narrowing between 24 mm and 34 mm long, in an artery between 2.50 mm and 4.25 mm wide, with at least 50% but less than 100% blockage, and with some blood flow still present (confirm specific measurements with trial site)

Who may not be able to join:

• People who are currently showing signs or test results consistent with an acute (sudden) heart attack
• People who have had a heart attack within the 72 hours before the procedure and whose blood enzyme levels (markers of heart damage such as CK-MB or Troponin) are above certain thresholds at the time of the procedure (confirm specific thresholds with trial site)
• People who have received an organ transplant or are currently on an organ transplant waiting list
• People who are receiving or scheduled to receive chemotherapy within 30 days before or after the procedure
• People who are taking oral or intravenous medications that suppress the immune system, or who have a life-limiting immune or autoimmune condition such as HIV or lupus (note: inhaled steroids and diabetes are not excluded)
• People who have been on long-term blood-thinning medication (for 72 hours or more) for reasons other than an acute coronary condition
• People whose platelet count (a measure of blood clotting cells) 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 who have a known or suspected liver disease, including laboratory signs of hepatitis
• People who are on dialysis or who have significantly reduced kidney function (confirm the specific measurement formula with trial site)
• People who have a history of bleeding or clotting disorders, 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 affect their ability to follow the trial requirements
• People whose target artery, or a branch of it, has been treated with any heart artery procedure within the 12 months before the trial procedure
• People whose target artery has been treated within 10 mm of the target blockage at any time in the past
• People whose non-target artery or branch has been treated with any heart artery procedure within 24 hours before the trial procedure
• People for whom certain unapproved devices or specific surgical tools are planned or used immediately before stent placement (confirm with trial site)
• People who have a further PCI procedure or bypass surgery planned after the trial procedure
• People who have previously received radiation therapy inside a coronary artery (intravascular brachytherapy)
• People who have a known allergy to any materials in the study stent or to required trial medications (such as certain metals, polymers, or drugs including aspirin and everolimus) that cannot be managed with pre-treatment
• People who have an active stomach ulcer or active gastrointestinal bleeding
• People who have another serious medical illness (such as cancer or severe heart failure) that may mean they are unlikely to survive beyond 24 months, a current substance abuse problem, or a planned medical procedure that could interfere with the trial
• People who are currently taking part in another clinical trial of an investigational drug or device that has not yet reached its main endpoint
• People who plan to join another investigational drug or device trial within 12 months after the procedure
• People who intend to become pregnant within 12 months after the procedure; women of childbearing age who are sexually active must agree to use reliable contraception from screening through 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 of childbearing age)
• People who have more than 2 target blockages, or more than 1 target blockage and 1 additional non-target blockage, to be treated during the trial procedure
• People whose target blockage is located in certain high-risk or complex positions in the heart arteries, including near the aorta, in the left main artery, near the origin of certain major branches, inside a bypass graft, involving significant side branches, with no or very limited blood flow, with severe artery twisting or angulation, with heavy calcium build-up, previously treated and re-narrowed, or with signs of a blood clot (confirm specific artery location criteria with trial site)
• People who have significant disease in the unprotected left main coronary artery (more than 50% blockage)
• People who have protected left main coronary artery disease and a target blockage in certain connected arteries (confirm with trial site)
• People who have another significant blockage in the target artery that is likely to need treatment within 12 months
• People who have two target blockages in the same artery that are less than 15 mm apart (note: multiple closely spaced narrowings that can be fully covered by one stent may be counted as a single blockage — confirm with trial site)

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