Endovascular placement of self-expanding nitinol coil stents for the treatment of femoropopliteal obstructive disease.
OBJECTIVE
To report on a prospective two-center study to evaluate safety and effectiveness of a self-expanding nitinol coil stent in patients with femoropopliteal obstructive disease.


METHODS
The IntraCoil nitinol stent was used in 37 patients (28 men and nine women; mean age, 62.4 y plus minus 10.7; range, 43-81 y) presenting with high-grade stenoses (n = 23) or short (<3 cm) occlusions (n = 17) of the superficial femoral artery (SFA; n = 33) or popliteal artery (n = 4). Indications for stent placement were significant residual stenosis (>30%) or dissection after angioplasty. Follow-up evaluations with measurement of the Doppler ankle-brachial index (ABI), assessment of Rutherford clinical stage, and color-coded duplex sonography were performed at discharge and 1, 3, 6, 12, and 18 months thereafter. Primary endpoints of the study were immediate technical and clinical success and 1-year patency.


RESULTS
Initial technical success was achieved in all patients. In 10 patients (27%), more than one 40-mm-long device had to be implanted for total lesion coverage; in three patients (8.1%), stents were placed in two separate segments of the SFA simultaneously. The total number of stents deployed was 50. Stent placement induced an initial improvement of the ABI from 0.54 plus minus 0.2 to 0.92 plus minus 0.11 (P <.01). Follow-up data for 12 months after treatment are available for 29 of 37 patients (78.4%); mean follow-up is 15.6 months (range, 1-26 mo). Primary patency rates at 6 and 12 months were 97.1% (SE = 2.9) and 86.2% (SE = 6.5). The primary assisted patency rate was 100% at 12 months.


CONCLUSIONS
Endovascular placement of the IntraCoil self-expanding nitinol coil stent for salvage of failed angioplasty in patients with femoropopliteal obstructive disease is an effective and safe procedure with promising mid-term results.
Jahnke
Thomas
T
Department of Diagnostic Radiology, University Hospital, Christian-Albrechts-Universität Kiel, Arnold-Heller Strasse 9, 24105 Kiel, Germany. cristea-jahnke@t-online.de
Voshage
Götz
G
Müller-Hülsbeck
Stefan
S
Grimm
Jan
J
Heller
Martin
M
Brossmann
Joachim
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D003251:Constriction, Pathologic / Q000628:therapy; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D011150:Popliteal Artery; D012449:Safety; D015607:Stents / Q000009:adverse effects*; D016896:Treatment Outcome
D000497:Alloys; C013616:nitinol