NCT01106391 - 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)

Coppi G, Njila M, Coppi G, Saitta G, Silingardi R, Pratesi C, Chiesa R, Scheinert D, Brunkwall JS, Torsello G
INCRAFT(R) Stent-Graft System: one-year outcome of the INNOVATION Trial. J Cardiovasc Surg (Torino). 2014 Feb;55(1):51-9.
Scheinert D, Pratesi C, Chiesa R, Coppi G, Brunkwall JS, Klarenbeek G, Cebrian A, Torsello G
First-in-human study of the INCRAFT endograft in patients with infrarenal abdominal aortic aneurysms in the INNOVATION trial. J Vasc Surg. 2013 Apr;57(4):906-14. doi: 10.1016/j.jvs.2012.09.079. Epub 2013 Jan 18.
Torsello G, Brunkwall J, Scheinert D
Cordis INCRAFT ultra-low profile AAA stent-graft system. J Cardiovasc Surg (Torino). 2011 Oct;52(5):661-7.
Torsello G, Scheinert D, Brunkwall JS, Chiesa R, Coppi G, Pratesi C
Safety and effectiveness of the INCRAFT AAA Stent Graft for endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2015 Jan;61(1):1-8. doi: 10.1016/j.jvs.2014.06.007. Epub 2014 Jul 19.

A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms

Clinical trial NCT01106391 - References