Bioequivalency Study of Amlodipine Tablets Under Fed Conditions
HypertensionChronic Stable Angina1 moreThe objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With...
Coronary Artery DiseaseAtherosclerosis5 moreThe objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).
Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina...
Angina CCS Classe II-IV - IMRRFR1 moreThe aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).
Influence of Naloxone on Ticagrelor Pharmacokinetics and Pharmacodynamics in Patients With Unstable...
Unstable Angina PectorisThe purpose of this study is to evaluate differences in the pharmacokinetics and pharmacodynamics of ticagrelor and its active metabolite between patients who received ticagrelor and morphine followed by naloxone versus patients treated with ticagrelor and morphine alone for unstable angina pectoris.
Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable...
Stable AnginaIn this study the investigators will use careful scientific blinding of patient and their subsequent healthcare staff so that the investigators can determine exactly how much difference coronary angioplasty makes to symptoms and blood supply to the heart. After the 6 weeks blinded phase, all patients will be unblinded and the patients who had undergone sham procedure will be offered the active therapy.
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation...
Coronary Artery DiseaseStable Angina Pectoris1 moreThe objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT.
Optical Coherence Tomography Comparison of Neointimal Coverage Between CRE8 DES and BMS
Stable AnginaUnstable Angina1 moreThe purpose of the study is to demonstrate the non-inferiority of Cre8 (CID) Drug Eluting Stent, studied 3 months after implant, compared to Vision/Multilink8 Bare Metal Stent (Abbott) studied at 1 month, in terms of neointimal coverage, determined by Optical Coherence Tomography (OCT), as percentage of cross-sections with RUTTS (Ratio of Uncovered to Total Stent Struts Per Cross Section) score ≤ 0.3.
Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina...
Ischemic Heart DiseaseRandomized clinical comparison of the serolimus eluting Cypher stent and the zotarolimus eluting Endeavor stent.
Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions
HypertensionChronic Stable Angina1 moreThe objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Drug-eluting Balloon in Bifurcations Trial
Coronary Artery DiseaseAtherosclerosis2 moreThe purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement). Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.