NCT03388021 - Clinical Trial References

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.

Citation(s)

Argyriou C, Georgakarakos E, Georgiadis GS, Antoniou GA, Schoretsanitis N, Lazarides M
Hybrid revascularization procedures in acute limb ischemia. Ann Vasc Surg. 2014 Aug;28(6):1456-62. doi: 10.1016/j.avsg.2014.01.019. Epub 2014 Feb 11.
de Donato G, Setacci F, Sirignano P, Galzerano G, Massaroni R, Setacci C
The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. J Vasc Surg. 2014 Mar;59(3):729-36. doi: 10.1016
Ouriel K
Endovascular techniques in the treatment of acute limb ischemia: thrombolytic agents, trials, and percutaneous mechanical thrombectomy techniques. Semin Vasc Surg. 2003 Dec;16(4):270-9. Review.
Rutherford RB
Clinical staging of acute limb ischemia as the basis for choice of revascularization method: when and how to intervene. Semin Vasc Surg. 2009 Mar;22(1):5-9. doi: 10.1053/j.semvascsurg.2008.12.003. Review.
Zaraca F, Ponzoni A, Sbraga P, Stringari C, Ebner JA, Ebner H
Does routine completion angiogram during embolectomy for acute upper-limb ischemia improve outcomes? Ann Vasc Surg. 2012 Nov;26(8):1064-70. doi: 10.1016/j.avsg.2011.12.012. Epub 2012 Jun 26.
Zaraca F, Stringari C, Ebner JA, Ebner H
Routine versus selective use of intraoperative angiography during thromboembolectomy for acute lower limb ischemia: analysis of outcomes. Ann Vasc Surg. 2010 Jul;24(5):621-7. doi: 10.1016/j.avsg.2009.12.006. Epub

Routine Versus Selective Completion Angiography After Thromboembolectomy in the Treatment of Acute Lower Limb Ischemia: A Randomized Controlled Trial

Clinical trial NCT03388021 - References