Product Surveillance Registry (PSR) Platform - Aortic, Peripheral & Venous (APV)
Enrolling By Invitation
18-100 years
All
Phase
4
100 participants needed
1 Location
Brief description of study
This post-market registry serves as an ongoing
source of product performance, patient safety, and clinical outcomes for a
variety of different products. The research design allows products to be added once
they are released on the market. Patients are enrolled and followed according
to their care provider’s normal care routine.
Detailed description of study
LG Health currently enrolls participants into two cohorts of
this registry.
1. AV Access
(Dialysis/Vascular)
The purpose
of this cohort is to evaluate the long-term safety of the IN.PACT™ AV Access
Drug Coated Balloon (DCB) for treatment of subjects with a new and/or non-stented
lesion of native Arteriovenous dialysis Fistulae (AVF) in the arm. Participants will be followed for five
years. There are no study site visits involved, only data collection.
2. Aortic
This cohort
is open to patients who received any eligible Medtronic product (stent graft)
used to treat diseases of the thoracic aorta, such as aneurysms or dissections.
The study team collects data about reinterventions, current health status,
adverse events, imaging results, and device issues. Participation lasts for as
long as they have the eligible Medtronic product or until the study closes. There
are no study site visits involved, only data collection.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Arteriovenous Fistula, Aortic Disease
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Patient or legally authorized representative provides written authorization and/or consent
- Patient within enrollment window relative to therapy initiation or meets criteria for retrospective enrollment
- Patient has or will soon receive or be treated with an eligible Medtronic product
Exclusion Criteria:
- Patient who is, or will be, inaccessible for follow-up
- Patient
is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
Updated on
09 Mar 2024.
Study ID: 2022-50
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