VISION and VQI Paclitaxel Safety Analysis (VISION-VQI)

December 16, 2019 updated by: Daniel Bertges, MD, University of Vermont Medical Center

Vascular Implant Surveillance and Interventional Outcomes Network and the Vascular Quality Initiative Paclitaxel Safety Analysis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 100 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients, aged 65 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 10/1/2012 and the latest available CMS dataset (12/31/2016) will be included.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall mortality
Time Frame: 1 year
death from any cause
1 year
overall mortality
Time Frame: 3 years
death from any cause
3 years
overall mortality
Time Frame: 5 years
death from any cause
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target vessel revascularization (TVR)
Time Frame: 1-3-5 years
repeat intervention on the SFA-popliteal artery including open or endovascular revascularization
1-3-5 years
Major amputation
Time Frame: 1-3-5 years
Major amputation for patients with chronic limb-threatening ischemia
1-3-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont Medical Center

Collaborators

Society for Vascular Surgery Patient Safety Organization
The Medical Device Epidemiology Network (MDEpiNet)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2012

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (ACTUAL)

December 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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