A Clinical Evaluation of Absorb™ Bioresorbable Vascular Scaffold (Absorb™ BVS) System in Chinese Population ~ ABSORB CHINA Randomized Controlled Trial (RCT)

Completed · Not applicable

Conditions studied: Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis

In brief

To evaluate the safety and efficacy of the Absorb BVS System compared to the XIENCE V Everolimus Eluting Coronary Stent System (EECSS) in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

Key facts

Study ID

NCT01923740

Run by

Abbott Medical Devices

People needed

480

Starts

2013-07-01

Expected to finish

2019-03-07

Last updated by the study team

2019-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be at least 18 years of age at the time of signing the informed consent form.
• Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
• Subject must have evidence of myocardial ischemia (e.g., stable angina, unstable angina, post-infarct angina or silent ischemia) suitable for elective percutaneous coronary intervention (PCI). Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objective sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG. In the absence of noninvasive ischemia, fractional flow reserve (FFR) must be done and indicative of ischemia.
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery.
• Female subject of childbearing potential does not plan pregnancy for up to 1 year following the index procedure. For a female subject of childbearing potential, a pregnancy test must be performed with negative results known within 14 days (≤14 days) prior to the index procedure per site standard test.
• Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
• Subject agrees to not participate in any other investigational clinical studies for a period of 1 year following the index procedure.

You may not qualify if…

• Any surgery requiring general anesthesia or discontinuation of aspirin and/or P2Y12 inhibitor is planned within 12 months after the index procedure.
• Subject has a known hypersensitivity or contraindication to device material (cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers) and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid). Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
• Subject has a known allergic reaction, hypersensitivity or contraindication to:
• Aspirin; or
• All P2Y12 inhibitors (including clopidogrel and ticlopidine, and prasugrel and ticagrelor when they become available); or
• Heparin and bivalirudin.
• Subject had an acute myocardial infarction (AMI) within 7 days of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure.
• Subject is currently experiencing clinical symptoms consistent with new onset AMI, such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.
• Subject has a cardiac arrhythmia as identified at the time of screening which at least one of the following criteria is met:
• Subject requires coumadin or any other agent for chronic oral anticoagulation.
• Subject likely to become hemodynamically unstable due to their arrhythmia.
• Subject has poor survival prognosis due to their arrhythmia.
• Subject has a known left ventricular ejection fraction (LVEF) < 30% assessed by any quantitative method. LVEF may be obtained within 6 months prior to the procedure for subjects with stable coronary artery disease (CAD). For subjects presenting with acute coronary syndrome (ACS), LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
• Subject has received CABG at any time in the past.
• Subject has undergone prior PCI within the target vessel during the last 12 months or undergone prior PCI within the non-target vessel within 30 days before the index procedure.
• Subject requires future staged PCI either in target or non-target vessels.
• Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
• At the time of screening, the subject has a malignancy that is not in remission.
• Subject is receiving immunosuppressant therapy or has known immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
• Subject has previously received or is scheduled to receive radiotherapy to coronary artery (vascular brachytherapy), or chest/mediastinum.
• Subject is receiving or will receive chronic anticoagulation therapy (e.g., coumadin or any other anticoagulation agents).
• Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3.
• Subject has a known or documented hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
• Subject has known renal insufficiency as defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 or dialysis at the time of screening.
• Subject is high risk of bleeding; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months; will refuse blood transfusions.

Where it is running

• Abbott Vascular — Santa Clara, California, United States

Full record on ClinicalTrials.gov

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