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Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease

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ClinicalTrials.gov Identifier: NCT04647643
Recruitment Status : Active, not recruiting
First Posted : December 1, 2020
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
National Evaluation System for health Technology Coordinating Center (NESTcc)
Society for Vascular Surgery Patient Safety Organization
Information provided by (Responsible Party):
Sourbha Dani, Lahey Clinic

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 U.S. commercial claims from the FAIR Health data warehouse.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Drug: Paclitaxel

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 U.S. 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 1/1/15 and 12/31/2019 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-PTX,with 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 4.01 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.

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Study Type : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Real-World Safety Analysis of Paclitaxel Devices Used for the Treatment of Peripheral Arterial Disease
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Group/Cohort Intervention/treatment
Paclitaxel Drug Coated Balloon
Patients treated with paclitaxel drug-coated balloon
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Name: Taxol

Paclitaxel Drug Coated Stent
Patients treated with paclitaxel drug-coated stent
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Name: Taxol




Primary Outcome Measures :
  1. Survival [ Time Frame: 4 years post intervention ]
    Freedom from death of any cause


Secondary Outcome Measures :
  1. Survival [ Time Frame: 2 years post intervention ]
    Freedom from death of any cause

  2. Retreatment [ Time Frame: 2 years post intervention ]
    Retreatment with repeat revascularization (open or endovascular)

  3. Amputation [ Time Frame: 2 years post intervention ]
    Freedom from amputation


Other Outcome Measures:
  1. Survival for age groups [ Time Frame: 4 years and 2 years post intervention ]
    Freedom from death in the age groups 18-34, 35-44, 45-54, 55-64, 65-74, 75 and above

  2. Survival for demographics and special baseline variables [ Time Frame: 4 years and 2 years post intervention ]
    Freedom from death in females, patients with claudication, CKD and dialysis, history of CAD, history of cancer

  3. Survival for special treatment category [ Time Frame: 4 years and 2 years post intervention ]
    Freedom from death in patients with patients receiving paclitaxel-coated device as a second procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Commercial claims of patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1/1/15 and 12/31/2019 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-PTX,with DCB patients, matched to patients treated with PTA, and DES patients matched to patients treated with BMS).
Criteria

Inclusion Criteria:

  • All patients, age 18 or older, who had a health insurance claim for outpatient endovascular treatment of the femoral or popliteal arteries for symptomatic PAD will be included. The diagnosis and treatment of PAD in the femoral and popliteal arteries will be identified by CPT/HCPCS and ICD-9 and ICD-10 PCS codes.
  • Presence of at least one additional outpatient or inpatient claims, at least 12 months following the index procedure, in order to demonstrate continued enrollment in health insurance coverage.

Exclusion Criteria:

  • Age <18 years
  • No qualifying peripheral arterial endovascular procedure
  • Inpatient procedure
  • Patients without any linked claim record more than 12 months after the index procedure, not known to have died or entered hospice care within the first 12 months

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): NCT04647643


Locations
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United States, Massachusetts
Lahey Clinic, Inc
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
National Evaluation System for health Technology Coordinating Center (NESTcc)
Society for Vascular Surgery Patient Safety Organization
Investigators
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Principal Investigator: Sourbha S Dani, MD, MSc Lahey Hospital & Medical Center
Study Director: Frederic S Resnic, MD, MSc Lahey Hospital & Medical Center
Study Chair: Robbert Zusterzeel, MD, MPH, PhD NESTcc
Additional Information:
Publications of Results:

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Responsible Party: Sourbha Dani, Staff Cardiologist, Lahey Clinic
ClinicalTrials.gov Identifier: NCT04647643    
Other Study ID Numbers: 20203069FH
6292-2020-2AS-1001-Phase1 ( Other Grant/Funding Number: NESTcc )
First Posted: December 1, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action