"The trial confirmed that the Tigertriever is not only safe and effective, but demonstrably improved outcomes over similar trials testing previous technology," Dr. Jeffrey L. Saver of the University of California, Los Angeles, said in a statement. The Tigertriever allows incremental control over the radial diameter and radial force of the thrombectomy basket.
Dr. Saver and his colleagues compared outcomes with the Tigertriever with efficacy and safety performance goals derived from outcomes in six recent pivotal studies evaluating the Solitaire (Medtronic) and Trevo (Stryker) stentrievers.
Participating sites with no experience with the Tigertriever device were required to complete a lead-in phase before participating in the main-study phase for primary endpoint analysis. The aim was to remove thrombus in patients with large-vessel occlusive stroke eligible for mechanical thrombectomy.
The team enrolled 160 patients (43 lead-in, 117 main phase) at 17 centers were enrolled. The primary efficacy endpoint of successful reperfusion within three passes of the Tigertriever was achieved without rescue therapy in 99 of the main-phase patients (85%). This exceeded the set 63% performance goal and the 73% historical rate and demonstrated non inferiority.
The primary safety endpoint, a composite of 90-day all-cause mortality and symptomatic intracranial hemorrhage, was 18% compared to a 30% performance goal and the 20% historical rate.
Good clinical outcome at three months was attained by 58%, a rate superior to the 44% in the pooled comparator trials. Results overall in lead-in patients did not differ significantly from those in main-study phase patients.
The researchers caution that theirs was "a single-arm trial against objective performance criteria derived from pooled prior studies of predicate devices, rather than a randomized trial with a contemporaneous control group." This approach, they add, "constrains precision in delineating how well the Tigertriever compares with any particular comparator device."
Nevertheless, they conclude, the Tigertriever achieved "non-inferiority over a performance goal and superiority over actual historical rates derived from trials and prospective studies of established devices."
The Tigertriever, already in use in Europe, received U.S. clearance for use in the treatment of ischemic stroke in March of this year, according to a statement by the company.
Dr. Saver and several of his coauthors report financial ties to Rapid Medical, Medtronic and Stryker.
SOURCE: https://bit.ly/39Hj9RQ Stroke, online March 20, 2021.
By Reuters Staff
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