Iakovou I, Ge L, Colombo A Contemporary stent treatment of coronary bifurcations. J Am Coll Cardiol. 2005 Oct 18;46(8):1446-55. Epub 2005 Sep 28. Review.
Karanasos A, Tu S, van der Heide E, Reiber JH, Regar E Carina shift as a mechanism for side-branch compromise following main vessel intervention: insights from three-dimensional optical coherence tomography. Cardiovasc Diagn Ther. 2012 Jun;2(2):173-7. doi: 10.3978/j.issn.2223-3652.2012.04.01.
Karanasos A, Tu S, van der Linden M, van Weenen S, Ligthart J, Regar E Online 3-dimensional rendering of optical coherence tomography images for the assessment of bifurcation intervention. Can J Cardiol. 2012 Nov-Dec;28(6):759.e1-3. doi: 10.1016/j.cjca.2012.04.017. Epub 2012 Jul 3.
Parikh K, Chandra P, Choksi N, Khanna P, Chambers J Safety and feasibility of orbital atherectomy for the treatment of calcified coronary lesions: the ORBIT I trial. Catheter Cardiovasc Interv. 2013 Jun 1;81(7):1134-9. doi: 10.1002/ccd.24700. Epub 2013 Mar 5.
Sharma SK, Sweeny J, Kini AS Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001. Review.
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.