VQI-PTX: VQI DELTA Paclitaxel Device Safety Analysis

Sponsor

Lahey Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04110288

Collaborator

Society for Vascular Surgery Patient Safety Organization (Other)

219,483

Enrollment

Location

Actual Duration (Months)

5632.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Disease	Drug: Paclitaxel Device: Non-drug coated Device 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:

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.
Paclitaxel delivering DES (including the Cook Zilver PTX and Boston Scientific Eluvia DES) as compared with propensity matched cases using bare metal stents (BMS).
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 Design

Study Type:

Observational

Actual Enrollment :

219483 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Aug 30, 2019

Actual Study Completion Date :

Apr 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Survival from Death [2 years post intervention]
Freedom from death of any cause

Secondary Outcome Measures

Intervention Success [2 year post intervention]
Freedom from death (any cause), re-treatment or major amputation
Successful Ambulation [1 year post intervention]
Successfully ambulating, ambulating with assistance or with prosthesis

Other Outcome Measures

Falsification - Freedom from Resuming Smoking [2 year post intervention]
Not resuming smoking post procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lahey Clinic, Inc.	Burlington	Massachusetts	United States	01805

Sponsors and Collaborators

Lahey Clinic
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