Coronary Artery Disease — Safety and Efficacy Study of the Amaranth Medical MAGNITUDE Bioresorbable Drug-Eluting Coronary Stent (RENASCENT III)
Citation(s)
Colombo A, for the FORTITUDE Study Investigators 1-Year Clinical and Imaging Outcomes of a Novel Ultra High Molecular Weight PLLA Sirolimus-Eluting Coronary BRS: A Prospective Multicenter International Investigation (The FORTITUDE® Study). TCT presentation 2016.
Granada JF BRS with clinical data III, Amaranth: Differentiating features and clinical update. TCT presentation 2014.
Granada JF From Aptitude to Magnitude: Progress Towards the Development of a Thin-Walled Novel PLLA Based Bioresorbable Scaffold. TCT presentation 2016.
Granada JF The Amaranth PLLA based bioresorbable scaffold (ABRS): Experimental and early human results. TCT presentation 2013.
Restoring Endoluminal Narrowing Using Bioresorbable Scaffolds - Extended Trial III
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
