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

NCT04647643 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8000

Last updated 2022-02-14

No results posted yet for this 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.

Conditions

  • Peripheral Arterial Disease

Interventions

DRUG

Paclitaxel

Paclitaxel to treat peripheral arterial disease

Sponsors & Collaborators

  • National Evaluation System for health Technology Coordinating Center

    collaborator OTHER

  • Society for Vascular Surgery Patient Safety Organization

    collaborator OTHER

  • Lahey Clinic

    lead OTHER

Principal Investigators

  • Sourbha S Dani, MD, MSc · Lahey Hospital & Medical Center

  • Frederic S Resnic, MD, MSc · Lahey Hospital & Medical Center

  • Robbert Zusterzeel, MD, MPH, PhD · NESTcc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04647643 on ClinicalTrials.gov