SWEDEPAD Trials Explore Resumption of Enrollment
May 31, 2019—Investigators from the SWEDEPAD 1 and 2 trials are aiming to resume recruitment of patients, having reviewed mortality data from the trials following concerns raised by the Katsanos meta-analysis published in December 2018. Enrollment in these lower extremity revascularization studies was paused while data were reviewed.
Principal Investigator Mårtin Falkenberg, PhD, and Steering Committee Chair Joakim Nordanstig, MD, provided the following comment to Endovascular Today:
On April 28th, the SWEDEPAD DSMC reviewed updated mortality data for the SWEDEPAD trials and recommended restart of recruitment to SWEDEPAD 1 and 2. On May 2nd, the SWEDEPAD steering committee decided to follow this recommendation and explore the possibility to restart the trials with the following prerequisites: (1) updated written patient information, (2) renewed ethical committee approval, and (3) informing regulatory authorities about our preliminary mortality data.
We believe the results of the upcoming FDA hearing will be quite important.
During the recent Paris Course on Revascularization (PCR) meeting, PCR issued a statement strongly supporting the resumption of the SWEDEPAD trials and the UK-based BASIL-3 trial.
For more on the upcoming FDA panel hearing, please see our interview with members of the FDA's Center for Devices and Radiological Health.
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