Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Debrecen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary artery diseae with revascularization indicated | Active Comparator | Subjects with coronary artery disease, that require and are eligible for percutaneous revascularization. |
|
| Coronary artery disease not requiring revascularization | No Intervention | Subjects with coronary artery disease that do not require revascularization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous coronary intervention with new generation fully resorbable scaffold | Device |
|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Intravascular ultrasound findings in coronaries | Minimum Lumen Area (MLA) | At index procedure |
| Intravascular ultrasound findings in coronaries | Percent Atheroma Volume (PAV) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Heart and Vascular Center | Budapest | 1122 | Hungary |
Not provided
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At index procedure |
| Intravascular ultrasound findings in coronaries | Area Stenosis (AS) | At index procedure |
| Intravascular ultrasound findings in coronaries | Negative or positive remodelling index (RI) | At index procedure |
| Intravascular ultrasound findings in coronaries | Intimal thickness (IT) | At index procedure |
| Intravascular ultrasound findings in coronaries | Calcification Index (CI) | At index procedure |
| Optical coherence tomography findings in coronaries | Intima to Media ratio (I/M ratio) | At index procedure |
| Optical coherence tomography findings in coronaries | Excentric intima hyperplasia | At index procedure |
| Optical coherence tomography findings in coronaries | Thin Cap Fibroatheroma presence (TCFA) | At index procedure |
| Optical coherence tomography findings in coronaries | Macrophage infiltration | At index procedure |
| Optical coherence tomography findings in coronaries | Intramural hematoma formation | At index procedure |
| Optical coherence tomography findings in coronaries | Intimal laceration | At index procedure |
| Optical coherence tomography findings in coronaries | Microchannel formation | At index procedure |
| Optical coherence tomography findings in coronaries | Lipid pool formation | At index procedure |
| D002318 |
| Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |