NL-OMON55997
Recruiting
Not Applicable
on-inferiority of Angiography-derived Physiology Guidance Versus Usual Care in an All-comers PCI Population Treated With Unrestricted Use of the Healing-Targeted Supreme (HT Supreme) Drug-eluting Stent and P2Y12 Inhibitor Monotherapy After 1-month of Dual-antiplatelet Therapy: the PIONEER IV trial - PIONEER-IV Study
niversity of Galway-Prof.James Livesey (Vice President of Research)0 sites595 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary artery disease
- Sponsor
- niversity of Galway-Prof.James Livesey (Vice President of Research)
- Enrollment
- 595
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female patient \>\=18 years of age;
- •2\. Patient has chronic stable angina, acute coronary syndromes or silent
- •3\. Presence of one or more coronary artery stenoses of \>\=50% (by visual
- •assessment) in a native coronary artery (with or without prior stent/other
- •device treatment) or in a saphenous venous or arterial bypass conduit suitable
- •for coronary stent implantation;
- •4\. The vessel should have a reference vessel diameter of at least 2\.25 mm by
- •visual assessment (no limitation on the number of treated lesions, vessels, or
- •lesion length);
- •5\. Patient has been informed of the nature of the study and agrees to its
Exclusion Criteria
- •1\. Patient is a woman who is pregnant or nursing (a pregnancy test must be
- •performed within 7 days prior to the index procedure in women of child\-bearing
- •potential according to local practice);
- •2\. Known intolerance to cobalt chromium, and medications such as sirolimus,
- •aspirin, heparin, bivalirudin or P2Y12 inhibitors;
- •3\. Planned major elective surgery requiring discontinuation of (D)APT within 12
- •months of procedure;
- •4\. Concurrent medical condition with a life expectancy of less than 3 years;
- •5\. Currently participating in another trial and not yet at its primary
- •6\. Active pathological bleeding;
Outcomes
Primary Outcomes
Not specified
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