Crossing chronic total occlusions with a new 0.014'' CiTop guidewire: proof of concept
Mickey Scheinowitz1, Irit Amrami, Uri Oppenhaim
1Neufeld Cardiac Research Institute and Department of Biomedical Engineering, Tel-Aviv University, Israel. mickey.scheinowitz@medstar.net
Insights
The new 0.014-inch CiTop guidewire shows promise for crossing chronic total occlusions (CTO) in peripheral and coronary arteries. This guidewire achieved a 90% success rate in human amputation models with minimal complications.
Area of Science:
- Cardiovascular Interventions
- Medical Device Technology
- Vascular Surgery
Background:
- Chronic arterial occlusions present a significant challenge in coronary and peripheral interventions.
- Despite technological advancements, effectively treating these occlusions remains a key obstacle.
Purpose of the Study:
- To assess the feasibility of the 0.014-inch CiTop guidewire for navigating total arterial occlusions.
- To establish a proof of concept for this novel guidewire in both normal and diseased vasculature.
Main Methods:
- The 0.014-inch CiTop guidewire, an over-the-wire catheter, was evaluated in swine models (n=7) and human amputations (n=10).
- Testing involved assessing guidewire performance in normal peripheral/coronary arteries and in totally occluded arterial lesions.
Main Results:
- The CiTop guidewire successfully traversed 90% of chronic total occlusions in human amputation arterial segments.
- Successful deployment was observed in seven peripheral and 12 coronary arteries of swine without causing arterial damage.
- The average time to cross occlusions was 4.6 ± 5.6 minutes, with one instance of perforation (10%).
Conclusions:
- The 0.014-inch CiTop guidewire demonstrates safe and effective penetration of total arterial occlusions.
- The device shows good operability in normal swine arteries and minimal complications in occluded human vessels.
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.
