MISAGO 1: first-in-man clinical trial with Misago nitinol stent.
OBJECTIVE
To evaluate a newly developed self-expanding Misago (Terumo Corp., Tokyo, Japan) nitinol stent with rapid exchange delivery catheter for the treatment of stenotic or occluded superficial femoral (SF) or popliteal arteries.


RESULTS
MISAGO 1 clinical trial enrolled 55 patients undergoing percutaneous intervention of totally occluded or stenotic lesions in SF or popliteal arteries treated with the implantation of 81 stents in five centres across Europe. Primary endpoint was restenosis rate at six months assessed by duplex sonography. Patients (67% male) were 68+/-9 years old, 60% were smokers and 31% had diabetes. Clinical symptoms of ischaemia were present in all patients. Average lesion length was 85+/-50 mm, 64% were totally occluded and 38% classified as TASC C or D. The technical success rate was 100% while the procedural success rate was 98.2% without death, MI, stroke, or major bleeding. At six months follow-up the restenosis rate was 8.5%. One patient (1.8%) died of bronchial carcinoma and two (3.6%) underwent target vessel revascularisation. Mean ankle brachial index improved from 0.70 at baseline to 0.95 at six months while walking capacity on treadmill test improved with an average of 147 m. Rutherford index at six months demonstrated improvement of 72%, without any patients having symptom deterioration. One case of stent fracture was observed.


CONCLUSIONS
The results from this first-in-man study indicate good safety and short to medium term efficacy profile of the Misago nitinol stent.
Schulte
Karl-Ludwig
KL
Vascular Center Berlin /Dept Internal Medicine, Ev Hospital Königin Elisabeth Herzberge, Berlin, Germany. kschulte@keh-berlin.de
Müller-Hülsbeck
Stefan
S
Cao
Piergiorgio
P
Becquemin
Jean-Pierre
JP
Langhoff
Ralf
R
Charalambous
Nikolas
N
Desgranges
Pascal
P
Kobeiter
Hicham
H
Midulla
Marco
M
Vladimir Borovicanin
Vladimir
V
Paunovic
Dragica
D
Beregi
Jean-Paul
JP
D000368:Aged; D000497:Alloys; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D005060:Europe; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D011150:Popliteal Artery; D012189:Retrospective Studies; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex
D000497:Alloys; C013616:nitinol