Intravascular Ultrasound Guidance for Complex High-Risk Indicated Procedures

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 620

Inclusion Criteria

1. The patient must be >=18 years of age
2. Patients with an indication for PCI of at least one lesion satisfying any of
the following criteria:
a. Angiographic heavy calcification
b. Ostial lesions
c. True bifurcation lesions involving side-branches >2.5mm
d. Left main lesions
e. Chronic total occlusion
f. In-stent restenosis
g. Long-lesions (estimated stent length > 28mm)
OR
Patient with an indication for PCI for any lesion and in need for elective
mechanical circulatory support assisted PCI
3. Presenting with silent ischemia, stable angina, unstable angina or recent
non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with the Synergy stent system,
Synergy Megatron system, or other Synergy platform iteration
5. The patient is willing and able to cooperate with study procedures and
follow-up until study completion
6. Subject is able to confirm understanding of risks, benefits and treatment
alternatives and he/she provides informed consent prior to any protocol-related
procedure, as approved by the appropriate Ethics Committee

Exclusion Criteria

1. ST-elevation myocardial infarction, cardiogenic shock
2. Known untreated severe valvular heart disease
3. Known contraindication or hypersensitivity to everolimus, platinum-chromium,
or to anticoagulants
4. Absolute contraindications or allergy that cannot be pre-medicated, to
iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12
inhibitors
5. Non-cardiac co-morbidities with a life expectancy less than 1 year
6. Currently participating in another trial that is not yet at its primary
endpoint. The patient is not allowed to participate in another investigational
device or drug study for at least 12 months after enrollment and may only be
enrolled once in the study
7. Women of childbearing potential who do not have a negative pregnancy test
within 7 days before the procedure and women who are breastfeeding
8. Subject belongs to a vulnerable population (per investigator*s judgment) or
subject unable to read or write

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>Target-vessel failure defined as a composite of cardiac death, target vessel<br /><br>myocardial infarction, or clinically indicated target-vessel revascularization<br /><br>ARC-2 1; 4th universal definition for spontaneous (>48 hours) MI 2. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br />1. Composite of target-vessel myocardial infarction and clinically indicated<br />target vessel revascularization<br />2. Clinically-indicated target vessel revascularization<br />3. Composite of cardiac death and target-vessel myocardial infarction<br />4. Target-Lesion Failure (TLF) defined as a composite of cardiac death, target<br />vessel myocardial infarction, or clinically indicated target-lesion<br />revascularization<br />5. Target-lesion revascularization<br />6. Cardiac death</p>