Status:
COMPLETED
Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Medtronic
Philips Healthcare
Conditions:
Peripheral Arterial Disease
Paclitaxel Adverse Reaction
Eligibility:
All Genders
66+ years
Brief 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...
Detailed Description
This is an observational retrospective cohort study using claims data to evaluate the long-term safety of paclitaxel-coated devices compared with non-drug coated devices for femoropopliteal artery rev...
Eligibility Criteria
Inclusion
- All fee-for-service Medicare beneficiaries who underwent femoropopliteal artery revascularization. Patients are allowed to undergo simultaneous revascularization of lesions outside this target vessel during the same procedure.
- All patients with ≥1 year of Medicare claims data prior to their index procedure.
Exclusion
- Patients without 1 year of Medicare claims data prior to their index revascularization procedure.
- Patients that do not have both a carrier file charge and an institutional file charge on the date of an outpatient procedure. This removes procedures performed in certain clinical settings, such as office-based clinics, that do not submit the Healthcare Common Procedure Coding System (HCPCS) code needed to identify drug-coated devices.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
168553 Patients enrolled
Trial Details
Trial ID
NCT04496544
Start Date
July 1 2020
End Date
June 30 2024
Last Update
August 9 2024
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215