VQI DELTA Paclitaxel Device Safety Analysis (VQI-PTX)

October 13, 2020 updated by: Frederic S. Resnic, Lahey Clinic

Vascular Quality Initiative (VQI) - Data Extraction and Longitudinal Trend Analysis (DELTA) Paclitaxel Device Safety Analysis - Phase I Study

The VQI-DELTA Paclitaxel Device Safety Analysis seeks to assess the comparative safety of paclitaxel coated balloons and stents in the treatment of peripheral artery disease (PAD) through analysis of the VQI Peripheral Vascular Intervention (PVI) registry module using the DELTA system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The VQI-DELTA 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 using the DELTA system.

The objective of the VQI - DELTA Paclitaxel Phase I Study is to evaluate the relative safety of Paclitaxel used as an antiproliferative agent in the treatment of symptomatic PAD. The study will analyze Paclitaxel Drug Coated Balloons (DCB) and Paclitaxel Drug Eluting Stents (DES), both together and as unique exposures using propensity score matched survival analysis. If a mortality signal is detected, factors associated with late mortality will be further explored. Phase I is the retrospective component of the planned study, evaluating the 2-year survival of patients treated with a paclitaxel containing/eluting device to matched patients treated with non-paclitaxel devices for symptomatic PAD.

All proposed analyses will be performed using DELTA v3.x, which has the capability to prospectively monitor clinical data repositories for safety signals, and is designed to support risk-adjusted prospective safety surveillance analyses of complex clinical datasets.

Three principle analyses are planned:

  1. Paclitaxel DCB (including the Bard Lutonix, Medtronic In.Pact and Philips Spectranetics Stellarex DCB's) as compared with propensity matched patients treated with plain balloons.
  2. Paclitaxel delivering DES (including the Cook Zilver PTX and Boston Scientific Eluvia DES) 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).

Study Type

Observational

Enrollment (Actual)

219483

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic, Inc.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients, age 18 or older, who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic PAD between 1/1/17 through 4/1/2020 will be candidates for inclusion in the analyses.

Description

Inclusion Criteria:

  • All patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic Peripheral Artery Disease.

Exclusion Criteria:

  • In an effort to focus this safety evaluation on those patients being treated in accordance with accepted 'best practice' endovascular intervention strategies and 'on-label' use of devices, patients will be excluded from either exposure cases or controls if they received a balloon expandable stent or a balloon expandable stent graft in the treatment of femoral or popliteal disease. Balloon expandable stents were excluded because these stents have historically shown inferior patency and current best practice favors placement of self-expanding nitinol stents which were engineered for the femoral popliteal segment and tested in multiple trials for this indication 12-14.

Additionally, patients will be excluded (as either potential cases or controls) if their index procedure was performed for acute limb ischemia due to the different etiologies (embolism, in-situ thrombosis) as compared with chronic conditions as they have different treatment paradigms and higher major amputation and mortality rates.

In addition, patients with prior angioplasty or stenting of the superficial femoral artery (SFA)-popliteal segment will be excluded in order to avoid the possibility of improperly assigning paclitaxel exposure to the control group.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Uncoated Balloon Treatment
Patients treated for PAD with balloon angioplasty, without use of stent.
Device: Non-drug coated Device Treatment
Bare Metal Stent Treatment
Patients treated for PAD with implantation of bare metal stent.
Device: Non-drug coated Device Treatment
Paclitaxel Coated Balloon
Patients treated for PAD with drug coated balloon angioplasty, without use of stent.
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Names:
  • Taxol
Paclitaxel Eluting Stent
Patients treated for PAD with implantation of Paclitaxel DES.
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival from Death
Time Frame: 2 years post intervention
Freedom from death of any cause
2 years post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Success
Time Frame: 2 year post intervention
Freedom from death (any cause), re-treatment or major amputation
2 year post intervention
Successful Ambulation
Time Frame: 1 year post intervention
Successfully ambulating, ambulating with assistance or with prosthesis
1 year post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Falsification - Freedom from Resuming Smoking
Time Frame: 2 year post intervention
Not resuming smoking post procedure
2 year post intervention

Collaborators and Investigators

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

Sponsor

Lahey Clinic

Collaborators

Society for Vascular Surgery Patient Safety Organization

Investigators

  • Principal Investigator: Frederic S Resnic, MD MSc, Lahey Hospital & Medical Center
  • Study Chair: Daniel Bertges, MD, Society for Vascuar Surgery Patient Safety Organization
  • Study Director: Jens Eldrup-Jorgensen, MD, Society for Vascuar Surgery Patient Safety Organization

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)

January 1, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

September 27, 2019

First Posted (Actual)

October 1, 2019

Study Record Updates

Last Update Posted (Actual)

October 19, 2020

Last Update Submitted That Met QC Criteria

October 13, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20193123
  • U01FD004963 (U.S. FDA Grant/Contract)

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

Yes

Studies a U.S. FDA-regulated device product

No

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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