Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04647643
Status:
COMPLETED
Last Update Posted:
2022-02-14
First Post:
2020-11-23
Brief Title:
Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Sponsor:
Lahey Clinic
Organization:
Lahey Clinic
Study Overview
Official Title:
Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Treatment with paclitaxel-based endovascular devices PED has become a common treatment option for patients with peripheral artery disease PAD involving the femoral-popliteal artery However an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals though there are significant limitations of these analyses Exploration of real-world data has been suggested as a means to further investigate the safety of PED The current study explores the association of PED and mortality in real-world data using US commercial claims from the FAIR Health data warehouse
Detailed Description:
Treatment with paclitaxel-based endovascular devices PED has become a common treatment option for patients with peripheral artery disease PAD involving the femoral-popliteal artery However an aggregate level meta-analysis identified an association between the use of PED and increased all-cause mortality at both two and five-year follow-up intervals though there are significant limitations of these analyses Exploration of real-world data has been suggested as a means to further investigate the safety of PED The current study explores the association of PED and mortality in real-world data using US commercial claims from the FAIR Health data warehouse
This study aims to evaluate the relative safety of paclitaxel used as an antiproliferative agent in the treatment of symptomatic PAD in a real-world scenario We will analyze Paclitaxel Drug-Coated Balloons DCB and Paclitaxel Drug-Eluting Stents DES in aggregate and as unique exposures using propensity score-matched survival analysis Inverse probability of Treatment Weighting
Commercial claims of patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1115 and 12312019 will form the study population Three separate safety analyses will be performed 1 Paclitaxel Drug coated balloons DCB as compared with propensity-matched patients treated with plain transluminal balloon angioplasty PTA 2 Paclitaxel delivering Drug-Eluting Stents DES as compared with propensity-matched cases using bare-metal stents BMS 3 Patients treated with either paclitaxel DCB or paclitaxel DES any PTX compared with propensity-matched controls non-PTXwith DCB patients matched to patients treated with PTA and DES patients matched to patients treated with BMS
All proposed analyses will be performed using R 401 implemented within the DELTA analytic engine DELTA is an active surveillance safety system that can monitor clinical data repositories for safety signals and has been validated to support risk-adjusted prospective safety surveillance analyses of complex clinical datasets
This study aims to evaluate the relative safety of paclitaxel used as an antiproliferative agent in the treatment of symptomatic PAD in a real-world scenario We will analyze Paclitaxel Drug-Coated Balloons DCB and Paclitaxel Drug-Eluting Stents DES in aggregate and as unique exposures using propensity score-matched survival analysis Inverse probability of Treatment Weighting
Commercial claims of patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1115 and 12312019 will form the study population Three separate safety analyses will be performed 1 Paclitaxel Drug coated balloons DCB as compared with propensity-matched patients treated with plain transluminal balloon angioplasty PTA 2 Paclitaxel delivering Drug-Eluting Stents DES as compared with propensity-matched cases using bare-metal stents BMS 3 Patients treated with either paclitaxel DCB or paclitaxel DES any PTX compared with propensity-matched controls non-PTXwith DCB patients matched to patients treated with PTA and DES patients matched to patients treated with BMS
All proposed analyses will be performed using R 401 implemented within the DELTA analytic engine DELTA is an active surveillance safety system that can monitor clinical data repositories for safety signals and has been validated to support risk-adjusted prospective safety surveillance analyses of complex clinical datasets
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 6292-2020-2AS-1001-Phase1 | OTHER_GRANT | NESTcc | None |