VQI DELTA Paclitaxel Device Safety Analysis
Completed
Conditions studied: Peripheral Vascular Disease
In brief
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.
Key facts
- Study ID
- NCT04110288
- Run by
- Lahey Clinic
- People needed
- 219483
- Starts
- 2017-01-01
- Expected to finish
- 2020-04-01
- Last updated by the study team
- 2020-10-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients who underwent endovascular interventional treatment of the femoral or popliteal arteries for symptomatic Peripheral Artery Disease.
You may not qualify if…
- 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.
Where it is running
- Lahey Clinic, Inc. — Burlington, Massachusetts, United States
Full record on ClinicalTrials.gov
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