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

Peripheral Arterial Disease Clinical Trial

— SAFE-PAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04496544
• Other study ID #: 2019P000950
• Status: Active, not recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 revascularization, with median follow-up time for the population surpassing 5 years. A series of supplemental sensitivity analyses will be conducted to assess and mitigate the potential for unmeasured confounding and to determine the impact of repeat interventions and paclitaxel exposure on survival. Finally, sub-group analyses will be performed to investigate whether there is differential safety of paclitaxel-coated devices across different patient profiles.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250000
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Paclitaxel Adverse Reaction
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Safety Issues

Intervention

Other:
• Retrospective data collection
No intervention; retrospective data collection

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Cook Medical, Medtronic, Philips Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices	Time from index procedure date to the date of death, to be updated periodically until the median duration of follow-up for the cohort reaches 5 years
Secondary	Repeat hospitalization	Rates of repeat hospitalization	1, 2 and 3 years after index procedure
Secondary	Repeat endovascular or surgical revascularization	Rates of repeat endovascular or surgical revascularization	1, 2 and 3 years after index procedure
Secondary	Target vessel revascularization	Rates of target vessel revascularization among inpatient procedures	1, 2 and 3 years after index procedure
Secondary	Lower extremity amputation	Rates of lower extremity amputation	1, 2 and 3 years after index procedure
Secondary	Optimal medical therapy	Rates of optimal medical therapy	1, 2 and 3 years after index procedure