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VISION-VQI: VISION and VQI Paclitaxel Safety Analysis

Sponsor
University of Vermont Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04204564
Collaborator
The Medical Device Epidemiology Network (MDEpiNet) (Other), Society for Vascular Surgery Patient Safety Organization (Other)
20,000
Enrollment
92
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: pactlitaxel PAD device

Detailed Description

The proposed safety analyses will evaluate two types of paclitaxel-coated interventional devices used to treat PAD and compare patient outcomes with propensity score-matched patients of similar risk who receive non-paclitaxel devices.

The primary outcome will be freedom from all-cause death using propensity-matched survival analysis.

Three principle analyses are planned:

  1. Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact Admiral, and Philips Spectranetics Stellarex DCB's) as compared with propensity-matched patients treated with plain balloons.

  2. Paclitaxel delivering DES (Cook Zilver PTX) as compared with propensity-matched cases using bare-metal stents (BMS).

  3. Patients treated with either Paclitaxel DCB or Paclitaxel DES compared with propensity-matched controls (with DCB patients matched to patients treated with plain balloons, and DES patients matched to patients treated with BMS).

Note that this analysis is planned at the device class level and is not intended to compare early or late mortality between specific devices or brands.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Vascular Implant Surveillance and Interventional Outcomes Network and the Vascular Quality Initiative Paclitaxel Safety Analysis
Actual Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Dec 31, 2016
Anticipated Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
paclitaxel coated balloon angioplasty

Procedures with paclitaxel coated balloon angioplasty of the superficial femoral-popliteal artery

Device: pactlitaxel PAD device
Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
Other Names:
  • Medtronic INPact Admiral
  • Bard Lutonix
  • Cook Zilver PTX stent

    		•
    plain balloon angioplasty

    Procedures with plain balloon angioplasty of the superficial femoral-popliteal artery
    paclitaxel eluting stent

    Procedures with paclitaxel eluting stenting of the superficial femoral-popliteal artery

    Device: pactlitaxel PAD device
    Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
    Other Names:
  • Medtronic INPact Admiral
  • Bard Lutonix
  • Cook Zilver PTX stent

    		•
    bare metal stenting

    Procedures with bare metal self expanding stenting of the superficial femoral-popliteal artery

    Outcome Measures

    Primary Outcome Measures

    1. overall mortality [1 year]

      death from any cause

    2. overall mortality [3 years]

      death from any cause

    3. overall mortality [5 years]

      death from any cause

    Secondary Outcome Measures

    1. target vessel revascularization (TVR) [1-3-5 years]

      repeat intervention on the SFA-popliteal artery including open or endovascular revascularization

    2. Major amputation [1-3-5 years]

      Major amputation for patients with chronic limb-threatening ischemia

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age ≥ 65 years old

    • Date of index procedure is within 10/1/2012 to 12/31/2016

    • Symptomatic disease ranging from intermittent claudication to chronic limb-threatening ischemia (including ischemic rest pain and/or tissue loss)

    • Elective or urgent procedures

    Exclusion Criteria:

    • Aneurysmal disease of the superficial femoral or popliteal artery

    • Treatment for acute limb ischemia

    • Treatment of common femoral artery or profunda femoral artery occlusive disease

    • Emergency procedures

    • PVI and concomitant femoral endarterectomy, suprainguinal or infrainguinal bypass

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Vermont Medical Center
    • The Medical Device Epidemiology Network (MDEpiNet)
    • Society for Vascular Surgery Patient Safety Organization

    Investigators

    • Principal Investigator: Daniel Bertges, MD, SVS VQI
    • Study Director: Philip Goodney, MD, SVS VQI
    • Study Director: Art Sedrakyan, PhD, Weill Medical College of Cornell University
    • Study Chair: Jens Jorgensen, SVS PSO

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Daniel Bertges, MD, Associate Professor of Surgery and Medicine, University of Vermont Medical Center
    ClinicalTrials.gov Identifier:
    NCT04204564
    Other Study ID Numbers:
    • 1
    First Posted:
    Dec 19, 2019
    Last Update Posted:
    Dec 19, 2019
    Last Verified:
    Dec 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    Yes
    Keywords provided by Daniel Bertges, MD, Associate Professor of Surgery and Medicine, University of Vermont Medical Center
    paclitaxel
    drug coated balloon
    drug eluting stent
    perihpheral vascular intervention
    registry

    Study Results

    No Results Posted as of Dec 19, 2019