PRospective Evaluation of complete revascularization in patients with multiveSsel disease Excluding chroNic Total occlusions
- Conditions
- stable coronary artery disease and non-ST ACS10011082
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 350
1. Age >= 18 years, <=85 years
2. 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
3. Patient indication, lesion length and vessel diameter of the target
lesion(s) are according to the *Instructions for Use* that comes with every
Resolute Onyx (Zotarolimus-Eluting stent) system.
4. The patient is willing and able to cooperate with study procedures and
required follow up visits
5. 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
1. Age <18 years and > 85 years.
2. Single coronary vessel disease.
3. No left anterior descending lesion.
4. Patients in cardiogenic shock.
5. Patients with STEMI.
6. Presence of a chronic total occlusion (CTO) defined as coronary lesion with
Thrombolysis in Myocardial Infarction (TIMI) flow grade 0 on initial
angiography present for more than or equal to 3 months.
7. Left main coronary artery disease
8. Patients who cannot give informed consent or have a life expectancy of less
than 12 months.
9. 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.
10. Patients with an extreme LAD tortuosity imparing OCT catheter advancement
11. 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 PRESENT study.
12. Previous coronary artery bypass grafting (CABG).
13. Patient requiring additional cardiac surgery within 6 months.
14. Women of childbearing potential who do not have a negative pregnancy test
result within 7 days before the procedure, women who are known to be pregnant,
or who are breastfeeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is defined as the composite of death from any cause,<br /><br>stroke, myocardial infarction, or repeat revascularization (MACCE) at 1-year<br /><br>post index procedure, which was compared with a pre-specified objective<br /><br>performance goal (OPG).</p><br>
- Secondary Outcome Measures
Name Time Method