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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04496544
Recruitment Status : Active, not recruiting
First Posted : August 3, 2020
Last Update Posted : May 6, 2023
Sponsor:
Collaborators:
Medtronic
Philips Healthcare
Bard Peripheral Vascular, Inc.
Boston Scientific Corporation
Cook Medical
Information provided by (Responsible Party):
Eric Secemsky, Beth Israel Deaconess Medical Center

Study Description
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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 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.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Paclitaxel Adverse Reaction Safety Issues Other: Retrospective data collection

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 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 250000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Groups and Cohorts
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Group/Cohort Intervention/treatment
Drug-Coated Devices
Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with drug-coated devices (drug-eluting stent ± drug-coated balloon, bare metal stent with drug-coated balloon, or drug-coated balloon alone)
 Other: Retrospective data collection
No intervention; retrospective data collection
Non-Drug-Coated Devices
Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with non-drug-coated devices (bare metal stent ± percutaneous transluminal balloon angioplasty or percutaneous transluminal balloon angioplasty alone)
 Other: Retrospective data collection
No intervention; retrospective data collection


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 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 ]
    All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices


Secondary Outcome Measures :
  1. Repeat hospitalization [ Time Frame: 1, 2 and 3 years after index procedure ]
    Rates of repeat hospitalization

  2. Repeat endovascular or surgical revascularization [ Time Frame: 1, 2 and 3 years after index procedure ]
    Rates of repeat endovascular or surgical revascularization

  3. Target vessel revascularization [ Time Frame: 1, 2 and 3 years after index procedure ]
    Rates of target vessel revascularization among inpatient procedures

  4. Lower extremity amputation [ Time Frame: 1, 2 and 3 years after index procedure ]
    Rates of lower extremity amputation

  5. Optimal medical therapy [ Time Frame: 1, 2 and 3 years after index procedure ]
    Rates of optimal medical therapy


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   66 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study cohort will include all Medicare fee-for-service beneficiaries who underwent femoropopliteal artery revascularization with either drug-coated devices (drug-eluting stent [DES] ± drug-coated balloon [DCB], bare metal stent [BMS] with DCB, or DCB alone) or non-drug-coated devices (BMS ± percutaneous transluminal angioplasty [PTA] or PTA alone). Each group will additionally be composed of two device-specific subgroups: a DCB sub-group and DES sub-group in the drug-coated group, and a PTA sub-group and a BMS sub-group in the non-drug group.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496544


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Medtronic
Philips Healthcare
Bard Peripheral Vascular, Inc.
Boston Scientific Corporation
Cook Medical
Investigators
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Principal Investigator: Eric A Secemsky, MD Beth Israel Deaconess Medical Center
Principal Investigator: Robert W Yeh, MD Beth Israel Deaconess Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eric Secemsky, Assistant Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04496544    
Other Study ID Numbers: 2019P000950
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As restricted by the data use agreement with the Centers for Medicare and Medicaid Services (CMS), we will not allow any data sharing for this project and we will not make any distribution of the CMS data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases