Direct stenting with a combined intravascular ultrasound-coronary stent delivery platform: a feasibility trial.
IVUS is considered as the most accurate tool for the assessment of optimal stent deployment. Direct stenting has shown to be a safe, efficient, and resource-saving procedure in selected patients. In a prospective 1-month feasibility trial, a new combined IVUS-coronary stent delivery platform (Josonics Flex, Jomed, Helsingborn, Sweden) was evaluated during direct stenting in consecutive patients considered eligible for direct stenting. The feasibility endpoint was successful stent deployment without any clinical adverse event, while the efficacy endpoint was strategic adaptation according to standard IVUS criteria for optimal stent deployment at the intermediate phase (after a result considered angiographically optimal) and at the end of the intervention (after optimization according to IVUS standards). A total of 16 patients were successfully treated with this device without any major clinical complication. At the intermediate phase, optimal stent deployment was achieved in four patients only, while at the end only one patient had nonoptimal IVUS stent deployment. In particular, the minimal in-stent cross-section area increased from 6.3 +/- 1.2 to 8.3 +/- 2.5 mm(2). These preliminary data demonstrate the feasibility of direct stenting with a combined IVUS-stent catheter in selected patients and confirm the results from larger randomized trials on the impact of IVUS on strategic adaptations during coronary stent placement.
Eeckhout
Eric
E
Cardiology Clinic, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. eric.eeckhout@chuv.hospvd.ch
Berger
Alexandre
A
Roguelov
Christan
C
Lyon
Xavier
X
Imsand
Christophe
C
Fivaz-Arbane
Malika
M
Girod
Grégoire
G
De Benedetti
Edoardo
E
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation*; D019917:Blood Vessel Prosthesis Implantation / Q000295:instrumentation*; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D015607:Stents; D018084:Ultrasonography, Interventional / Q000295:instrumentation*