Investigator-initiated clinical trial of stabilizer device: A novel intracranial exchange guidewire for neuroendovascular treatments.

BACKGROUND

Neuroendovascular procedures, especially those involving significant vessel tortuosity, giant intracranial aneurysms, or distally located lesions, frequently necessitate exchange methods. However, exchange maneuvers pose a risk of inadvertent vessel injury. To address these challenges, a Stabilizer device was developed and evaluated for its efficacy and safety. This clinical trial aimed to assess the efficacy and safety of the Stabilizer device in facilitating the navigation of neuroendovascular devices to target lesions in cases where the exchange technique was necessary.

METHODS

This was a single-arm, prospective, open-label, multicenter clinical trial performed at nine different sites. It focused on investigating the use of the Stabilizer device for treating intracranial aneurysms and atherosclerosis.

RESULTS

A total of 31 patients were enrolled across nine centers in Japan from July 21, 2022, to March 10, 2023. The study enrolled 24 (77.4%) patients with intracranial aneurysms and seven (22.6%) patients with intracranial artery stenosis. Majority of the target lesions were in the middle cerebral artery territory (83.9%). The Stabilizer device was used to exchange for 0.027-inch catheters, intermediate catheters, PTA balloons, and Wingspan stent system. The Stabilizer device demonstrated 100% technical success rate. While three complications related to the treatment were noted, there were no complications related to the device, including any vascular damage.

CONCLUSIONS

This is the first multicenter clinical trial that investigated and demonstrated technical efficacy as well as overall safety profile of the Stabilizer device in neuroendovascular procedures where the use of an exchange method was necessary.

Déclaration de conflit d'intérêts

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: This trial received trial devices and granted from Bolt Medical. The authors, NS, NK, and ST, were consultants of Bolt Medical at the treatment, but declare that this trial was conducted in the absence of any commercial or financial relationships that could be constructed as a potential conflict of interest. NS received a research grant from Japan Lifeline, Kaneka, Medtronic, Terumo, and TG Medical; lecturer’s fees from Asahi-Intec, Kaneka, Medtronic, Stryker, and Terumo; membership on the advisory boards for Johnson & Johnson, Medtronic, and Terumo, outside of this article. HI received lecturer's fee from Medtronic. NK has been a consultant for Stryker and Medtronic, outside of this article. ST received research funds from Biomedical Solutions, Rapid Medical, and Medtronic, and a consultant for TG Medical, Irvine Neurovascular, Balt USA, Cerenovus, Medtronic, Phenox GmbH, MicroVention, Kaneka USA, Century Medical Inc., EnCompass, NVMedTech, and Stryker, outside of this article.