CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8,000 enrolled
Drug / intervention
Paclitaxeldrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04647643
NCT04647643N/ACompleted

Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease

Lahey Clinic·observational·Posted Dec 1, 2020·Updated Feb 14, 2022

In Brief

An observational study evaluating Paclitaxel for Peripheral Arterial Disease. Completed, enrolled 8,000 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 1, 2020
Enrollment StartNov 20, 2020
Primary CompletionDec 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.6 years ago

Interventions

Paclitaxeldrug

Paclitaxel to treat peripheral arterial disease