FIM

First In Man Trial

Objective

The objective of the FIM Trial was to evaluate the feasibility and safety of the novel MGuard stent when used in PCI of human native coronary arteries and SVGs.

Study design

The FIM trial was conducted in 2 centers in Germany and evaluated the feasibility and safety of MGuard-based PCIs in 41 patients (males: 78%, diabetics: 39%; prior MI: 29%; prior PCI: 51%; prior CABG: 68%) with lesions located in human native coronary arteries (n=33) and SVGs (n=23) (2). The primary endpoint was 30-day major adverse cardiac events (MACE) including cardiac death, myocardial infarction, stent thrombosis and repeat target lesion revascularization.

Results

Device and procedural success were 100% and 95.1%, respectively. Two patients experienced a procedure-related CPK rise. Thirty-day MACE occurred in 3/41 patients (7.3%) and included 3 cases of MI (two non-Q wave MIs and 1 Q-wave MI) and 1 case of target lesion revascularization (TLR). At 6 months, 9/41 patients (22.0%) had MACE that were mainly presented by TLR (8/41 patients; 19.5%). There were no cases of fatality or new MIs. By angiographic follow-up at 6 month, 19.4% of the patients had in-stent restenosis and 22.2% had in-segment restenosis. Mean in-stent and in-segment late loss was 0.93 and 0.79 mm, respectively (2).

Extended follow-up

An extended follow-up reported that MACE rate at 20 months was 24.4%. This included one case of death, one case of Q-wave MI, 2 cases of non-Q wave MI, and 9 cases of TLR. In conclusion, in the First in Man study, the MGuardTM stent proved to be safe and efficient in patients with stable and acute coronary syndromes with lesion located in native coronary arteries and SVGs. The extended follow-up MACE results were considered to be encouraging by the authors in view of the unfavorable patient and lesion characteristics (1).

Conclusion

The MGuardTM stent proved to be safe and efficient in patients with stable and acute coronary syndromes with lesion located in native coronary arteries and SVGs.

References

1. Grube E, Hauptmann KE, Muller R, Uriel N, Kaluski E. 2011. Coronary stenting with MGuard: extended follow-up of first human trial. Cardiovasc Revasc Med 12:138-46

2. Kaluski E, Hauptmann KE, Muller R, Tsai S, Klapholz M, Grube E. 2008. Coronary stenting with MGuard: first-in-man trial. J Invasive Cardiol 20:511-5