NCT00542646 - 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)

Carnevale K, Ouriel K, Gabriel Y, Clair D, Bena JF, Silva MB, Sarac TP
Biological coating for arterial stents: the next evolutionary change in stents. J Endovasc Ther. 2006 Apr;13(2):164-74.
Sarac TP, Carnevale K, Smedira N, Tanquilut E, Augustinos P, Patel A, Naska T, Clair D, Ouriel K
In vivo and mechanical properties of peritoneum/fascia as a novel arterial substitute. J Vasc Surg. 2005 Mar;41(3):490-7.

Pilot Study to Evaluate the Safety and Preliminary Efficacy of the Peritec Peritoneal Lined Stent and Delivery System

Clinical trial NCT00542646 - References