Coronary Artery and Systemic Autoimmune Disease: Diagnostics and Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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In Vivo Intravascular Diagnostics and Evaluation of New Therapeutic Modalities in Systemic Autoimmune and Coronary Artery Disease Patients

Conditions
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Autoimmune Diseases, Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous coronary intervention with new generation fully resorbable scaffold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 18+ years Signed and dated informed consent form Manifest autoimmune disease, consisting either of: rheumatoid arthritis or systemic lupus erythematosus or systemic sclerosis or mixed connective tissue disease under the care of a clinical immunologist Clinical indication for a coronary angiography as determined by a cardiologist Exclusion Criteria: Age of 75+ years Glomerular filtration rate of under 30 ml/min Severely decreased left ventricular function (ejection fraction <35%) Pregnancy or nursing Unclear immunological diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coronary artery diseae with revascularization indicated<br>Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization. | Device: Percutaneous coronary intervention with new generation fully resorbable scaffold<br> <br> |
| No Intervention: Coronary artery disease not requiring revascularization<br>Subjects with coronary artery disease that do not require revascularization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebral events | Eligible for patients in clinical need for revascularization undergoing percutaneous revascularization with a bioresorbable vascular scaffold | From index procedure to 5 years |