NCT01726257 - 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)

Kisis K, Krievins D, Naskovica K, Gedins M, Savlovskis J, Ezite N, Lietuvietis E, Zarins K
Quality of life after endovascular abdominal aortic aneurysm repair: nellix sac-anchoring endoprosthesis versus open surgery. Medicina (Kaunas). 2012;48(6):286-91.
Krievins DK, Holden A, Savlovskis J, Calderas C, Donayre CE, Moll FL, Katzen B, Zarins CK
EVAR using the Nellix Sac-anchoring endoprosthesis: treatment of favourable and adverse anatomy. Eur J Vasc Endovasc Surg. 2011 Jul;42(1):38-46. doi: 10.1016/j.ejvs.2011.03.007. Epub 2011 Apr 15.

Prospective, Multicenter, Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System: A Pivotal and Continued Access Study

Details for clinical trial NCT01726257

Clinical trial NCT01726257 - References