High-frequency mechanical vibration to recanalize chronic total occlusions after failure to cross with conventional guidewires.
BACKGROUND
Crossing chronic total occlusions (CTO) of coronary arteries continues to challenge interventional cardiologists. A clinical study was undertaken in four European centers to examine the feasibility of using the new CROSSER system that utilizes high-frequency mechanical vibration to penetrate atherosclerotic plaque material to cross CTOs in patients where conventional guidewire techniques had failed. The objective of the study was to determine whether the CROSSER system could safely cross such CTOs.


METHODS
A total of 55 CTO lesions in 53 patients were treated in two clinical phases: (1) Phase 1 feasibility study (30 CTOs), with a primary focus on device safety; and (2) Phase 2 pivotal study (25 CTOs) using an improved version of the device, with a primary focus on effectiveness.


RESULTS
The primary endpoint of device efficacy and the secondary endpoint of clinical success were both 76% (19 of 25) in the pivotal study phase. No major adverse cardiac events of death, Q-wave myocardial infarction or target lesion revascularization (by either coronary artery bypass graft surgery or percutaneous coronary intervention) were observed through 30-day follow up. No coronary perforation or pericardial tamponade occurred.


CONCLUSIONS
The CROSSER system is a safe device that can cross many occlusions after a conventional guidewire failure. With additional refinement and improvements to the device, this success rate could be further increased.
Grube
Eberhard
E
Klinikum Siegburg, Siegburg, Germany.
Sütsch
Gabor
G
Lim
Victor Y
VY
Buellesfeld
Lutz
L
Iakovou
Ioannis
I
Vitrella
Giancarlo
G
Colombo
Antonio
A
D000328:Adult; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002114:Calcinosis / Q000000981:diagnostic imaging / Q000628:therapy; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D019233:Retreatment; D015607:Stents; D017211:Treatment Failure; D016896:Treatment Outcome; D014732:Vibration / Q000627:therapeutic use*