Status:
COMPLETED
VQI DELTA Paclitaxel Device Safety Analysis
Lead Sponsor:
Lahey Clinic
Collaborating Sponsors:
Society for Vascular Surgery Patient Safety Organization
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18+ years
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 ...
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 Initiat...
Eligibility Criteria
Inclusion
- All patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic Peripheral Artery Disease.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
219483 Patients enrolled
Trial Details
Trial ID
NCT04110288
Start Date
January 1 2017
End Date
April 1 2020
Last Update
October 19 2020
Active Locations (1)
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1
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805