NCT04496544

Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168,553 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 66 Years
• Healthy volunteers: Not accepted

Summary

The SAFE-PAD Study aims to evaluate the long-term safety of paclitaxel-coated devices compared with non-paclitaxel-coated devices for femoropopliteal artery revascularization among a broad, real-world population of patients with peripheral artery disease. This multi-year analysis aims to create an ongoing mechanism to evaluate the safety of paclitaxel-coated devices in real world practice. The null hypothesis is that the paclitaxel-coated devices are associated with an increase in mortality relative to the non-drug-coated devices beyond an acceptable magnitude (i.e. the non-inferiority margin), and the alternative hypothesis is that paclitaxel-coated devices are not associated with an increase in mortality relative to the non-drug-coated devices beyond the non-inferiority margin.

Detailed description

This is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery revascularization, with median follow-up time for the population surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess and mitigate the potential for unmeasured confounding and to determine the impact of repeat interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be performed to investigate whether there is differential safety of paclitaxel-coated devices across different patient profiles.

Conditions

• Peripheral Arterial Disease
• Paclitaxel Adverse Reaction
• Safety Issues

Interventions

Type	Name	Description
OTHER	Retrospective data collection	No intervention; retrospective data collection

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-03-19
• Completion: 2024-06-30
• First posted: 2020-08-03
• Last updated: 2024-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study