NCT01514916 - 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)

Ferrari E, Tozzi P, von Segesser LK
The Vascular Join: a new sutureless anastomotic device to perform end-to-end anastomosis. Preliminary results in an animal model. Interact Cardiovasc Thorac Surg. 2007 Feb;6(1):5-8. Epub 2006 Nov 20.
Tozzi P, Borghi E, Haesler E, Siniscalchi G, Motti A, Hayoz D, von Segesser LK
Progress in cardiovascular anastomoses: will the vascular join replace Carrel's technique? Eur J Cardiothorac Surg. 2006 Sep;30(3):425-30. Epub 2006 Jul 20.
Tozzi P, Solem JO, Boumzebra D, Mucciolo A, Genton CY, Chaubert P, von Segesser LK
Is the GraftConnector a valid alternative to running suture in end-to-side coronary arteries anastomoses? Ann Thorac Surg. 2001 Sep;72(3):S999-1003.

Evaluation of a Mechanical System (Vascular Join) Facilitating Arterial Anastomoses During Peripheral Vascular Surgery (Bypass).

Clinical trial NCT01514916 - References