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VQI DELTA Paclitaxel Device Safety Analysis (VQI-PTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110288
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Society for Vascular Surgery Patient Safety Organization
Information provided by (Responsible Party):
Frederic S. Resnic, Lahey Clinic

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
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:

  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).

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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 : January 1, 2017
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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 Name: Taxol

Paclitaxel Eluting Stent
Patients treated for PAD with implantation of Paclitaxel DES.
Drug: Paclitaxel
Paclitaxel to treat peripheral arterial disease
Other Name: Taxol




Primary Outcome Measures :
  1. Survival from Death [ Time Frame: 2 years post intervention ]
    Freedom from death of any cause


Secondary Outcome Measures :
  1. Intervention Success [ Time Frame: 2 year post intervention ]
    Freedom from death (any cause), re-treatment or major amputation

  2. Successful Ambulation [ Time Frame: 1 year post intervention ]
    Successfully ambulating, ambulating with assistance or with prosthesis


Other Outcome Measures:
  1. Falsification - Freedom from Resuming Smoking [ Time Frame: 2 year post intervention ]
    Not resuming smoking post procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110288


Locations
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United States, Massachusetts
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Society for Vascular Surgery Patient Safety Organization
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Frederic S. Resnic, Lahey Clinic:
Study Protocol  [PDF] May 20, 2020

Publications:

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Responsible Party: Frederic S. Resnic, Chair - Division of Cardiovascular Medicine, Lahey Clinic
ClinicalTrials.gov Identifier: NCT04110288    
Other Study ID Numbers: 20193123
U01FD004963 ( U.S. FDA Grant/Contract )
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action