High-frequency mechanical vibration to recanalize chronic total occlusions after failure to cross with conventional
Eberhard Grube1, Gabor Sütsch, Victor Y Lim
1Klinikum Siegburg, Siegburg, Germany.
Insights
The CROSSER system safely crosses chronic total occlusions (CTOs) when standard guidewires fail. This innovative device shows promise for improving interventional cardiology success rates in complex coronary artery disease cases.
Area of Science:
- Interventional Cardiology
- Medical Device Technology
- Cardiovascular Research
Background:
- Chronic total occlusions (CTOs) present significant challenges in coronary artery interventions.
- Conventional guidewire techniques often fail to cross these complex lesions.
- The CROSSER system, using high-frequency mechanical vibration, was developed to address this unmet need.
Purpose of the Study:
- To evaluate the feasibility and safety of the CROSSER system for crossing CTOs.
- To determine the effectiveness of the CROSSER system in patients who failed conventional guidewire crossing.
- To assess the primary endpoint of device efficacy and secondary endpoint of clinical success.
Main Methods:
- A two-phase clinical study involving 53 patients and 55 CTO lesions across four European centers.
- Phase 1 focused on device safety in 30 CTOs.
- Phase 2, the pivotal study, assessed effectiveness in 25 CTOs using an improved CROSSER device.
Main Results:
- The pivotal study phase demonstrated a 76% success rate for both device efficacy and clinical success (19 of 25 CTOs).
- No major adverse cardiac events, including death, myocardial infarction, or target lesion revascularization, were reported within 30-day follow-up.
- The study reported no instances of coronary perforation or pericardial tamponade, highlighting the device's safety profile.
Conclusions:
- The CROSSER system is a safe and effective device for crossing challenging coronary artery chronic total occlusions after conventional guidewire failure.
- The system shows potential to improve procedural success rates in complex coronary interventions.
- Further device refinement and improvements may lead to even higher success rates in future applications.
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.
Patients And 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.