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VISION and VQI Paclitaxel Safety Analysis

NCT04204564 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2019-12-19

No results posted yet for this study

Summary

Objectives

1. The VQI-VISION Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel-coated balloons and stents in the treatment of PAD through analysis of the Vascular Quality Initiative (VQI) Peripheral Vascular Intervention (PVI) registry module with linkage to claims. By linking VQI patients to Medicare claims retrospectively from 2012 to 2016, we will be able to identify additional paclitaxel devices enabling longitudinal follow-up of mortality out to 5 years for paclitaxel-eluting stents and 3 years for paclitaxel-coated balloons.
2. To analyze factors associated with mortality, specifically comparing paclitaxel patients surviving vs. paclitaxel patients with mortality. The goal is to identify independent factors predictive of mortality in US pivotal trials and model registry data exposures with sufficient factors to track competing risk paradox and show emulation or not of mortality outcomes with both PTX and PTA exposures.
3. To confirm the effectiveness of paclitaxel devices by comparing reintervention for paclitaxel and non-paclitaxel devices. In-hospital mortality from open and percutaneous target vessel revascularization (TVR) will be reported to determine the impact of subsequent revascularizations on survival. Major amputation will be comparted for patients with chronic limb-threatening ischemia.

Conditions

  • PAD

Interventions

DEVICE

pactlitaxel PAD device

Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.

Sponsors & Collaborators

  • The Medical Device Epidemiology Network (MDEpiNet)

    collaborator UNKNOWN

  • Society for Vascular Surgery Patient Safety Organization

    collaborator OTHER

  • University of Vermont Medical Center

    lead OTHER

Principal Investigators

  • Daniel Bertges, MD · SVS VQI

  • Philip Goodney, MD · SVS VQI

  • Art Sedrakyan, PhD · Weill Medical College of Cornell University

  • Jens Jorgensen · SVS PSO

Eligibility

Min Age
65 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-01
Primary Completion
2016-12-31
Completion
2020-06-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204564 on ClinicalTrials.gov