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

NCT04496544 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168553

Last updated 2024-08-09

No results posted yet for this 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.

Conditions

  • Peripheral Arterial Disease
  • Paclitaxel Adverse Reaction
  • Safety Issues

Interventions

OTHER

Retrospective data collection

No intervention; retrospective data collection

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Philips Healthcare

    collaborator INDUSTRY

  • Bard Peripheral Vascular, Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Cook Medical

    collaborator UNKNOWN

  • Beth Israel Deaconess Medical Center

    lead OTHER

Principal Investigators

  • Eric A Secemsky, MD · Beth Israel Deaconess Medical Center

  • Robert W Yeh, MD · Beth Israel Deaconess Medical Center

Eligibility

Min Age
66 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-03-19
Completion
2024-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT04496544 on ClinicalTrials.gov