The CAPTURE (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients) clinical trial is a first-in-human, four center, non-randomized, feasibility study of the CCA filter. An independent Data Safety Monitoring Board oversaw the safety of the trial, and an independent Clinical Events Committee adjudicated endpoint events.
The FIRE AND ICE trial is a multicenter, randomized, noninferiority, parallel-group, open-label trial, with blinded end-point assessment, in which cryoballoon ablation was compared with radiofrequency ablation.
The SABRE (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis) trial was a prospective, single-arm, feasibility study involving 9 European centers to evaluate the safety and effectiveness of the Virtue balloon for coronary ISR, and powered to demonstrate superiority over (historically documented) plain balloon angioplasty treatment.
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