A Phase 1b Study Evaluating RESTEN-MP in Subjects With Focal de Novo Stenosis
Coronary Artery Disease, Coronary Stent Restenosis
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring restenosis, in-stent restenosis
Eligibility Criteria
Inclusion Criteria: ≥ 19 and ≤ 80 years of age. The Subject must be properly consented following FDA regulations and guidelines. Male and Female volunteers with reproductive or childbearing potential must agree to practice adequate birth control methods to protect themselves and partners from conception . Subjects will be scheduled for percutaneous coronary intervention (PCI) due to first time implantation of a Taxus Express stent as a result of stenosis. Subject is an acceptable candidate for coronary artery bypass surgery. The Subject has no more than two lesions within the coronary arterial system requiring stent placement where the diameter of the affected artery or arteries is ≥ 2.5 mm and ≤ 4.9 mm based on angiography. The target lesion (and the secondary lesion, if applicable) is ≤ 20 mm in length via angiography. The Subject has had successful placement of a Taxus Express intracoronary stent(s). Subject agrees and is able to return for the scheduled study visits. Exclusion Criteria: One or more treatable lesions within the coronary arterial system requiring planned or staged intervention prior to the Month One visit. Multi-vessel coronary artery disease involving more than 2 vessels within the coronary arterial system requiring stent placement. Clinically significant findings for any body system that the Principal Investigator determines will exclude a Subject from safely participating in the study. A pregnant or nursing female. Positive history for HIV, HBV or HCV. In-stent restenosis in the target vessel. A target lesion located in an unprotected left main coronary artery or aorto-ostial location or in a bypass graft. Left ventricular ejection fraction < 30%. Angiographic evidence of the target vessel segment angulated ≥ 45º. Angiographic evidence of thrombus or severe calcification in the target lesion. History of bleeding disorders or coagulopathy. NYHA Class III congestive heart failure (CHF). Serum creatinine > 1.5 mg/dL. Clinically active cancer or any medical condition that may lead to study non-compliance or early study termination, confound the results, or is associated with limited life expectancy, i.e., less than 1 year. History of a stroke or trans-ischemic attack (TIA) within 6 months of angioplasty. Unstable ventricular arrhythmias. Evidence of an acute myocardial infarction within 72 hours of the intended treatment (defined as: Q wave or non-Q wave infarction having CK enzymes ≥ 2X the upper laboratory normal with the presence of a CK-MB elevated above the upper limit of normal) or acute myocardial infarction in progress at time of treatment. Known hypersensitivity to aspirin, clopidogrel, or heparin or a contraindication to receive the contrast agent administered during angiographic procedures. Unwilling to accept blood transfusions. Participant in an investigational device or drug study 30 days prior to randomization in this study. A stent other than the Taxus Express is placed. Unsuccessful intracoronary stent placement.