Coronary stenting with M-Guard: feasibility and safety porcine trial.
M-Guard is an ultra-thin polymer mesh sleeve attached to the external stent surface. It is designed to minimize distal embolization during coronary, renal, carotid and vein graft stenting. The polymer net could also serve as a platform for more uniform drug delivery.


OBJECTIVE
To evaluate coronary M-Guard stent deliverability and safety (stent thrombosis and restenosis) in comparison to bare-metal stents (BMS) in a porcine model of percutaneous coronary interventions (PCIs).


METHODS
Under general anesthesia using percutaneous technique, 6 swine received a total of 18 coronary stents: 5 BMS and 13 M-Guard-BMS. Quantitative coronary angiography (QCA) was obtained immediately prior to and post-PCI, and at 30 days post-stenting. At 30 days, all animals were sacrificed and hearts were sent to a core lab for coronary histology and histomorphometry. Primary endpoints were 30-day QCA percent diameter stenosis, late luminal loss and minimal luminal diameter (MLD). Secondary endpoints were procedural success, 30-day mortality and stent thrombosis. Exploratory endpoints were histology and histomorphometric analysis performed at 30 days on M-Guard stented segments.


RESULTS
All stents were delivered successfully. There were no procedural complications or porcine morbidity or mortality at 30 days. The M-Guard and BMS displayed similar results of MLD, late luminal loss and percent diameter stenosis at 1 month.


CONCLUSIONS
When compared to BMS, PCI with M-Guard-BMS is feasible, safe and yields similar inflammatory and restenotic response.
Kaluski
Edo
E
Department of Cardiology, University Medical Center, University of Medicine and Dentistry of New Jersey, Newark, NJ 07101, USA. kalusked@umdnj.edu
Groothuis
Adam
A
Klapholz
Marc
M
Seifart
Philip
P
Edelman
Elazar
E
D000818:Animals; D017023:Coronary Angiography; D003331:Coronary Vessels / Q000473:pathology; D004867:Equipment Design; D004869:Equipment Safety; D005240:Feasibility Studies; D006965:Hyperplasia; D015994:Incidence; D008297:Male; D015607:Stents / Q000009:adverse effects; D013552:Swine; D017539:Tunica Intima / Q000473:pathology