Crossing chronic total occlusions with a new 0.014'' CiTop guidewire: proof of concept.

OBJECTIVE

To evaluate the feasibility of a new 0.014'' CiTop guidewire to cross total occlusions within normal and diseased blood vessels; proof of concept.

BACKGROUND

Despite recent advances, chronic arterial occlusions remain the main obstacle of coronary and peripheral interventions.

METHODS

The OVALUM CiTop 0.014'' guidewire is an over-the-wire catheter designed to penetrate through chronic total occlusions (CTO) and allow for further PCI interventions. The CiTop guidewire was tested in normal peripheral and coronary arteries of swine (n = 7) and in totally occluded arterial lesions within human amputations (n = 10).

RESULTS

The CiTop 0.014'' guidewire was operated successfully in seven peripheral blood vessels and 12 coronary arteries without angiographic or histological evidence of damage to the arterial wall. The CiTop crossed 9 of the 10 occluded segments within the human amputation with no angiographic or histological evidence of arterial damage (90% success rate). Average time to cross the occlusion was 4.6 +/- 5.6 min. In one artery (10%), angiographic evidence of perforation was noted and there was histological evidence for arterial wall damage.

CONCLUSION

Our data show that the new 0.014'' CiTop guidewire can be well operated within normal peripheral and coronary arteries of swine, and with minimal complications within totally occluded blood vessels from human amputations while effectively penetrating and crossing total arterial occlusions.