Safety and efficacy of the SeparGateTM balloon-guiding catheter in neurointerventional surgery: A prospective, multicenter, single-arm clinical trial

Abstract

Objective

To evaluate the safety and efficacy of the SeparGate™ balloon-guiding catheter (BGC) for blocking flow and delivering devices in neurointerventional surgery.

Method

This prospective multicenter single-arm trial enrolled patients who received BGC adjuvant therapy to provide temporary blood flow arrest of the supra-aortic arch arteries and their branch vessels in interventional therapy. The primary endpoint was immediate procedural success rate in flow arrest, device delivery, and withdrawal. The efficacy endpoints were intraoperative product performance, including rigidity, smoothness, fracture resistance of the catheter wall, catheter push performance, compatibility and radiopaque display, integrity, adhesion thrombus after withdrawal and balloon rupture. The safety endpoints were adverse and serious adverse events associated with the test device and serious adverse events resulting in death or serious health deterioration.

Result

A total of 129 patients were included; of them, 128 were analyzed in the full analysis set (FAS) and per protocol set (PPS). Immediate procedural success was achieved in 97.7% of patients with FAS and PPS. The lower bound of the 95% confidence interval was 94.6%, higher than the preset efficacy margin of 94%. Device-related adverse events occurred in 2 (1.6%) cases. One was mild adverse event of vasospasm, which resolved spontaneously. The other was serious adverse event of dissection aggravation, which was treated with stenting angioplasty. No device defects were observed.

Conclusion

In neurointerventional surgery, the SeparGate™ BGC can be used to temporarily block the flow of the supra-aortic arch arteries and their branch vessels and guide the interventional device to the target vascular position.