Restenosis — Treatment of Coronary In-Stent Restenosis
Citation(s)
1 TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation J. van der Giessen, Circulation 2003,107:559-564: 2.Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. Kastrati A,JAMA 2005;293:165-71 3.Treatment of coronary in-stent restenosis with a paclitaxel-coated ballon catheter, B.Scheller, NEJM,355;20,Nov 16,2006 4.Randomized Trial of Paclitaxel- Versus Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents The ISAR-DESIRE 2 Study. Mehilli J, J Am Coll Cardiol 2010 Mar 5 5.Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. Stone GW,. N Engl J Med 2010 May 6;362:1663-74 6.Angiogaphic surrogate end points in drug-eluting stent trials, S.J.Pocock, JACC, Vol 51,No 1,2008
Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.
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.
