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Study hypothesis: the Stentys self-expandable Stent results into a better alignment of the struts to the vessel wall than a balloon-expandable stent within a few days after the procedure in acute myocardial infarction patients.
Stent strut malapposition and stent underexpansion are a common phenomenon in AMI as a result of the changing anatomy after an AMI has occurred (thrombus dissolution, resolution of spasm) with the traditional balloon-expandable stent treatment. A self-expanding stent might lead to better stent strut apposition as it follows the contours of the vessel wall due to its self-expanding properties. This might result into better long term clinical outcomes like lower thrombosis rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-expanding stent | Experimental | Stentys stent |
|
| Balloon-expandable stent | Active Comparator | VISION/Driver |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stentys coronary stent | Device | Self-expanding Nitinol stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stent strut apposition measured by optical coherence tomography (OCT) | 3 days after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | 30 days and 6 months |
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Inclusion Criteria:
Subject 18 years old.
Acute Myocardial Infarction defined as presence of at least two of the three items below:
Reperfusion expected to be achieved within 12 hours from the onset of symptoms
Subject understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
Subject is willing to comply with specified follow-up evaluation and can be contacted by telephone.
Acceptable candidate for coronary artery bypass graft (CABG) surgery.
Male or non-pregnant female subject.
Angiographic Inclusion Criteria:
Exclusion Criteria:
Angiographic Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Verheye, MD, Ph.D | ZNA, Middelheim, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C. Spaulding | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26549374 | Derived | Nakatani S, Onuma Y, Ishibashi Y, Karanasos A, Regar E, Garcia-Garcia HM, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Capodanno D, Van Langenhove G, Verheye S, Serruys PW, van Geuns RJ. Incidence and potential mechanism of resolved, persistent and newly acquired malapposition three days after implantation of self-expanding or balloon-expandable stents in a STEMI population: insights from optical coherence tomography in the APPOSITION II study. EuroIntervention. 2015 Dec;11(8):885-94. doi: 10.4244/EIJY15M11_01. | |
| 23257368 |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Balloon-expandable stent | Device | VISION/Driver |
|
|
| Derived |
| van Geuns RJ, Tamburino C, Fajadet J, Vrolix M, Witzenbichler B, Eeckhout E, Spaulding C, Reczuch K, La Manna A, Spaargaren R, Garcia-Garcia HM, Regar E, Capodanno D, Van Langenhove G, Verheye S. Self-expanding versus balloon-expandable stents in acute myocardial infarction: results from the APPOSITION II study: self-expanding stents in ST-segment elevation myocardial infarction. JACC Cardiovasc Interv. 2012 Dec;5(12):1209-19. doi: 10.1016/j.jcin.2012.08.016. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |