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NCT04647643 · ClinicalTrials.gov registry record
Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
A clinical trial, sponsored by Lahey Clinic.
- Completed
- Registry status
- 8,000
- Enrollment target
NCT04647643: Completed study, sponsored by Lahey Clinic.
NCT04647643 is a clinical trial that has completed, run by Lahey Clinic. The registered enrollment target is 8,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04647643 has completed, sponsored by Lahey Clinic.
- COMPLETED
- Registry status
- 8,000 participants
- Enrollment target
Study Summary
Treatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals, though there are significant limitations of these analyses. Exploration of real-world data has been suggested as a means to further investigate the safety of PED. The current study explores the association of PED and mortality in real-world data using U.S. commercial claims from the FAIR Health data warehouse.
Primary Outcome
Freedom from death of any cause
Interventions
- DRUG Paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,000 participants |
| Start Date | 2020-11-20 |
| Est. Completion | 2021-12-31 |
What the finished NCT04647643 record still lists
NCT04647643 is an observational study that tracks outcomes without assigning an intervention. Its 8,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which Paclitaxel is the first listed.
NCT04647643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04647643 about?
NCT04647643 is a clinical study titled "Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease". Treatment with paclitaxel-based endovascular devices (PED) has become a common treatment option for patients with peripheral artery disease (PAD) involving the femoral-popliteal artery. However, an aggregate level meta-analysis identified an association between the use of PED and increased all-cause...
What is the current status of trial NCT04647643?
This trial is currently completed. The enrollment target is 8,000 participants. The study started on 2020-11-20. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04647643?
The interventions under investigation include: Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT04647643?
This trial is sponsored by Lahey Clinic, which has 43 total clinical trials registered on ClinicalTrials.gov.
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