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In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients
This study evaluates in vivo intracoronary imaging using intravascular ultrasound and optical coherence tomography and safety and efficacy of new generation fully bioresorbable vascular scaffolds in four well defined systemic autoimmune (rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis, systemic lupus erythematosus) and concomitant coronary disease patients.
The aim of this study is to assess in vivo intracoronary anatomy using intravascular ultrasound and optical coherence tomography and assess the efficacy and safety of new generation fully bioresorbable vascular scaffolds in a systemic autoimmune and coronary heart disease patient population. The following four well defined systemic autoimmune entities are linked to increased cardiovascular risk: rheumatoid arthritis, mixed connective tissue disease, systemic sclerosis and systemic lupus erythematosus. One of the main causes of death in systemic autoimmune subjects is cardiovascular disease. In-vivo intracoronary anatomy and pathology regarding systemic autoimmune diseases is unknown. Furthermore, all forms of revascularization in such patients yield sub-optimal results, with poor outcomes using even the most modern drug eluting metallic stents. This may be linked to a long term exaggerated chronic inflammation response to the metallic components. Thus, fully bioresorbable vascular scaffolds may prove more efficacious in systemic autoimmune subjects.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Semmelweis University Heart and Vascular Center
Budapest, Hungary
Start Date
July 1, 2015
Primary Completion Date
March 1, 2021
Completion Date
March 1, 2021
Last Updated
April 23, 2021
11
ACTUAL participants
Percutaneous coronary intervention with new generation fully resorbable scaffold
DEVICE
Lead Sponsor
Semmelweis University Heart and Vascular Center
Collaborators
NCT06948110
NCT06342713
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05681702