Absorb GT1 Japan PMS

Summary

Participation Requirements

Description

The surveillance consists of two phases as detailed below. All patients will be continuously registered in each phases. Phase 1 (All- patients): Includes 250 patients (approximately 45 sites) Main Purpose: To confirm the efficacy of physician training and to establish optimal training for increasing...

The surveillance consists of two phases as detailed below. All patients will be continuously registered in each phases. Phase 1 (All- patients): Includes 250 patients (approximately 45 sites) Main Purpose: To confirm the efficacy of physician training and to establish optimal training for increasing medical institutions participating in post-marketing evaluation. Procedural results will be evaluated sequentially for early feedback to the sites. Therefore, there will be no quantitative goal established to move to Phase 2. However, recommended procedure may be updated as required in order to achieve optimal acute result. Phase 2 (All- patients): Until 2000 patients are registered (up to 200 sites) Main Purpose: To confirm safety. Target sample size of the Surveillance is approximately 2,000 patients. Commercial sale of Absorb GT1 beyond the purpose of the Surveillance will be started if the scaffold thrombosis (ST) rate in the 2,000 patients at 3 month is 0.9% or lower (ST rates for patients with Absorb GT1). In the ABSORB III (NCT01751906) clinical trial, 19 events of definite/probable ST reported through 1 year, and 18 of them except 1 occurred within 3 months (maximum of 78 days) post-procedure. Therefore, it is appropriate to perform interim analysis for the safety using ST rate through 3 months. The event occurred after 3 months was reported 362 days after the procedure, and the patient stopped treatment with thienopyridine antiplatelet agent on Day 356. Both in the AVJ-301 (NCT01844284) and the ABSORB III clinical trials, ST rate through 1 year was 1.5%. In the ABSORB III clinical trial, ST rate in target lesion with Reference Vessel Diameter (RVD) ? 2.25 mm was 0.9%. As explained above, ST rates at 3 months and 1 year are almost similar. The half widths of the 95% confidence intervals (CI) to different sample sizes are presented in the table 2.3-1. The half width of 95% CI decreases from 0.6% to 0.4% when a sample size is increased from 1,000 to 2,000. However, further increase in the sample size does not result in significant decrease in the half width of 95% CI. Therefore, the sample size of the Surveillance was established as 2,000 patients.

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