Direct Complete Versus Staged Complete Revascularization in Patients Presenting With Acute Coronary Syndromes and Multivessel Disease

Launched by ERASMUS MEDICAL CENTER · Aug 3, 2018

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to treat patients who have serious heart conditions called acute coronary syndromes (ACS), which can include conditions like heart attacks. The researchers want to find out if performing a complete revascularization (a procedure that opens up blocked blood vessels in the heart) right away is just as effective as doing it in two stages over the next six weeks. This trial includes patients with multiple blocked arteries who are eligible for a specific type of heart procedure called percutaneous coronary intervention (PCI).

To participate in the trial, patients need to be between 18 and 85 years old and have specific heart issues, like chest pain or changes seen on heart tests. They must also be suitable candidates for a particular heart stent, which helps keep blood vessels open. Participants will receive treatment and will need to attend follow-up visits to monitor their progress. It’s important to note that individuals with certain health conditions or those who have had recent heart procedures may not be eligible.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Inclusion criteria STEMI-ACS ST-segment elevation myocardial infarction (STEMI) Both criteria must be present for eligibility
• • Chest pain for more than 20 minutes with an electrocardiographic ST-segment elevation of 1 mm or greater in two or more contiguous leads, or with a new left bundle-branch block
• • Admission either within 12 hours of symptom onset or between 12 and 24 hours after onset with evidence of continuing ischemia.
• • Inclusion criteria for NSTE-ACS Non-ST-segment elevation myocardial infarction (NSTEMI) At least two of the following must be present for eligibility
• • History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
• • Coronary angiography with indication to PCI
• • Troponin T or I or creatine kinase MB above the upper limit of normal
• • Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts) 0 Unstable Angina (UA)
• At least two of the following must be present in the absence of cardiomyocyte necrosis (i.e. Troponin T or I and creatine kinase MB must be within normal limits):
• • History consistent with new, or worsening ischemia, occurring at rest or with minimal activity
• • Coronary angiography with indication to PCI
• • Electrocardiographic changes compatible with ischemia but not diagnostic for ST-segment elevation myocardial infarction (i.e. ST depression of 1 mm or greater in two contiguous leads, T-wave inversion more than 3 mm, or any dynamic ST shifts)
• General inclusion criteria:
• • Age ≥ 18 years ≤ 85 years
• • The patient is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use and the Declaration of Helsinki
• • Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Instructions for Use' that comes with every Biotronik Orsiro (Sirolimus-Eluting stent) system.
• • The patient is willing and able to cooperate with study procedures and the required follow up visits
• • The subject or legal representative has been informed of the nature of the study and agrees to its provisions and has provided an EC approved written informed consent, including data privacy authorization
• Exclusion Criteria:
• • Age \<18 years and \> 85 years
• • Single coronary vessel disease or multivessel disease without clear culprit
• • Patients in cardiogenic shock
• • Patients who cannot give informed consent or have a life expectancy of less than 1year
• • Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to any of the study medications, including both aspirin and P2Y12 inhibitors.
• • Enrollment in another study with another investigational device or drug trial that has not reached the primary endpoint . The patient may only be enrolled once in the BioVAsc study
• • PCI in the previous 30 days.
• • Presence of a chronic total occlusion
• • Previous CABG
• • Women of childbearing potential who do not have a negative pregnancy test within 7 days before the procedure and women who are breastfeeding.
• • Planned surgery within 6 months after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period