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NCT04496544 · ClinicalTrials.gov registry record
Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
A clinical trial, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 168,553
- Enrollment target
NCT04496544: Completed study, sponsored by Beth Israel Deaconess Medical Center.
NCT04496544 is a clinical trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 168,553 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04496544 has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 168,553 participants
- Enrollment target
Study 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.
Primary Outcome
All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices
Interventions
- OTHER Retrospective data collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168,553 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2024-06-30 |
What the finished NCT04496544 record still lists
NCT04496544 is an observational study that tracks outcomes without assigning an intervention. Its 168,553 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Retrospective data collection is the first listed.
NCT04496544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04496544 about?
NCT04496544 is a clinical study titled "Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)". 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 o...
What is the current status of trial NCT04496544?
This trial is currently completed. The enrollment target is 168,553 participants. The study started on 2020-07-01. Estimated completion is 2024-06-30.
What interventions are being tested in trial NCT04496544?
The interventions under investigation include: Retrospective data collection (OTHER).
Who is sponsoring clinical trial NCT04496544?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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