Shammas NW, Aasen N, Bailey L, Budrewicz J, Farago T, Jarvis G Two Blades-Up Runs Using the JetStream Navitus Atherectomy Device Achieve Optimal Tissue Debulking of Nonocclusive In-Stent Restenosis: Observations From a Porcine Stent/Balloon Injury Model. J Endovasc Ther. 2015 Aug;22(4):518-24. doi: 10.1177/1526602815592135. Epub 2015 Jun 24.
Shammas NW, Shammas GA, Aasen N, Jarvis G Number of Blades-up Runs Using JetStream XC Atherectomy for Optimal Tissue Debulking in Patients with Femoropopliteal Artery In-Stent Restenosis. J Vasc Interv Radiol. 2015 Dec;26(12):1847-51. doi: 10.1016/j.jvir.2015.08.026.
Shammas NW, Shammas GA, Banerjee S, Popma JJ, Mohammad A, Jerin M JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study. J Endovasc Ther. 2016 Apr;23(2):339-46. doi: 10.1177/1526602816634028. Epub 2016 Feb 26.
Shammas NW JETSTREAM Atherectomy: A Review of Technique, Tips, and Tricks in Treating the Femoropopliteal Lesions. Int J Angiol. 2015 Jun;24(2):81-6. doi: 10.1055/s-0034-1390083. Review.
JetStream Atherectomy for the Treatment of In-stent Restenosis of the Femoropopliteal Artery
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.
