For Physicians and Hospitals
The SVS PSO is partnering with the FDA and device manufacturers to use VQI to help meet device regulatory requirements. The quality of these devices is important for vascular healthcare, so this is an important aspect of the SVS PSO. Using VQI data for multiple stakeholders is also efficient, so that sites that participate in such projects do not need to enter data twice. Currently, there are post-approval surveillance projects available for VQI members, listed below, with several more in development.
Participation in the VQI is required to participate in these projects. Because these are quality improvement projects in the SVS PSO, and are surveillance of standard clinical practice with FDA approved devices, these are not studies that require IRB approval or informed consent. However, sites are reimbursed for the cost of additional data and follow-up entry that may be required for these projects, and participation is voluntary.
How to Participate:
- Join the Vascular Quality Initiative for the relevant VQI Registry.
- Complete and return the relevant project questionnaire to confirm your interest.
Current Medical Device Evaluation projects and site questionnaires:
Bard® LifeStent® Popliteal Stent Project
The Bard® LifeStent® Popliteal Stent Project is being conducted to further evaluate the Bard LifeStent for treatment of popliteal artery atherosclerosis.
Medtronic IN.PACT™ Admiral™ DCB ISR Project
The Medtronic IN.PACT™ Admiral™ DCB ISR Project is being conducted to confirm that IN.PACT Admiral DCBs are safe and effective for treatment of ISR lesions in the superficial femoral and popliteal arteries.
TEVAR Dissection Surveillance Project
Lombard Aorfix® Surveillance Project
Other Industry Projects
Bard LifeStent® Vascular Stent System: The project is titled, “A Prospective, Multicenter, Registry Surveillance of the Clinical Use of the Bard® LifeStent® Vascular Stent Systems in the Popliteal Artery Using the VQI PVI Registry”. The objective of this project is to conduct long term post-market surveillance of the safety (including fractures assessed at revision) and effectiveness of the Bard® LifeStent® Vascular Stent Systems for the treatment of symptomatic de novo or restenotic lesions in the popliteal artery. The project requires 74 patients, with procedure, as well as 1-year, and 2-year time points.
CREST2 Registry: M2S and the VQI were chosen by the principal investigators for the CREST-2 Randomized Control Trial (RCT) to collect procedural data and reports for this project. M2S contracts with sites for the associated CREST-2 Registry, which monitors volumes of carotid artery stent (CAS) procedures performed by potential CREST-2 interventionists until they achieve the minimum volume and quality to join the CREST-2 RCT.
For information about how to join the VQI to participate in these projects, contact VQI@m2s.com