Peripheral Arterial DiseaseSAFE-PADNCT04496544
Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
An observational study of Peripheral Arterial Disease and Paclitaxel Adverse Reaction, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 66 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Paclitaxel Adverse Reaction, Safety Issues
- What is being tested?
- Retrospective data collection
- How many people
- 168,553 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
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.
Read the 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.
- Being tested
- Retrospective data collection
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective data collectionOther
No intervention; retrospective data collection
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: 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) Receives: Other: Retrospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality of patients who underwent femoropopliteal artery revascularization with drug-coated devices or non-drug-coated devices
Measured: 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 outcomes (5)
Repeat hospitalization
Rates of repeat hospitalization
Measured: 1, 2 and 3 years after index procedure
Repeat endovascular or surgical revascularization
Rates of repeat endovascular or surgical revascularization
Measured: 1, 2 and 3 years after index procedure
Target vessel revascularization
Rates of target vessel revascularization among inpatient procedures
Measured: 1, 2 and 3 years after index procedure
Lower extremity amputation
Rates of lower extremity amputation
Measured: 1, 2 and 3 years after index procedure
Optimal medical therapy
Rates of optimal medical therapy
Measured: 1, 2 and 3 years after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start1 Jul 2020
- Primary completion19 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 168,553 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Philips Healthcare, Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Cook Medical
- Responsible party
- Principal investigator, Eric Secemsky, Beth Israel Deaconess Medical Center
- Investigators
- Eric A Secemsky, MD, Principal investigator, Beth Israel Deaconess Medical CenterRobert W Yeh, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496544
- Sponsor's protocol ID
- 2019P000950
- Acronym
- SAFE-PAD
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2020
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
Secemsky EA, Song Y, Schermerhorn M, Yeh RW. Update From the Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study. Circ Cardiovasc Interv. 2022 Jun;15(6):e012074. doi: 10.1161/CIRCINTERVENTIONS.122.012074. Epub 2022 May 20. No abstract available.
PubMed 35593638Secemsky EA, Raja A, Shen C, Valsdottir LR, Schermerhorn M, Yeh RW; SAFE-PAD Investigators. Rationale and Design of the SAFE-PAD Study. Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007040. doi: 10.1161/CIRCOUTCOMES.120.007040. Epub 2021 Jan 13.
PubMed 33435732
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of Femoropopliteal Endovascular Treatment With PAclitaxel-coated Devices (SAFE-PAD Study)
- ClinicalTrials.gov ID
- NCT04496544
- Acronym / sponsor ID
- SAFE-PAD / 2019P000950
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168,553 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic, Philips Healthcare, Bard Peripheral Vascular, Inc., Boston Scientific Corporation, Cook Medical
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-Coated Devices | – | Other: Retrospective data collectionMedicare 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) |
| Non-Drug-Coated Devices | – | Other: Retrospective data collectionMedicare 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) |
Who may qualify
- Ages
- 66 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective data collectionNo intervention; retrospective data collection | Other | Drug-Coated Devices, Non-Drug-Coated Devices |
Primary outcome
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
5 secondary outcomes
Repeat hospitalization
Time frame: 1, 2 and 3 years after index procedure
Repeat endovascular or surgical revascularization
Time frame: 1, 2 and 3 years after index procedure
Target vessel revascularization
Time frame: 1, 2 and 3 years after index procedure
Lower extremity amputation
Time frame: 1, 2 and 3 years after index procedure
Optimal medical therapy
Time frame: 1, 2 and 3 years after index procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 35593638Secemsky EA, Song Y, Schermerhorn M, Yeh RW. Update From the Longitudinal Assessment of Safety of Femoropopliteal Endovascular Treatment With Paclitaxel-Coated Devices Among Medicare Beneficiaries: The SAFE-PAD Study. Circ Cardiovasc Interv. 2022 Jun;15(6):e012074. doi: 10.1161/CIRCINTERVENTIONS.122.012074. Epub 2022 May 20. No abstract available.
- Derived from this study: PubMed 33435732Secemsky EA, Raja A, Shen C, Valsdottir LR, Schermerhorn M, Yeh RW; SAFE-PAD Investigators. Rationale and Design of the SAFE-PAD Study. Circ Cardiovasc Qual Outcomes. 2021 Jan;14(1):e007040. doi: 10.1161/CIRCOUTCOMES.120.007040. Epub 2021 Jan 13.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Secemsky, MD principal investigator
Beth Israel Deaconess Medical Center
Robert W Yeh, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Paclitaxel Adverse Reaction, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04496544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.