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

Recruiting

Conditions: Coronary artery disease
10011082

Registration Number: NL-OMON55997

Lead Sponsor: niversity of Galway-Prof.James Livesey (Vice President of Research)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 595

Inclusion Criteria

1. Male or female patient >=18 years of age;
2. Patient has chronic stable angina, acute coronary syndromes or silent
ischemia;
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
provisions and has provided written informed consent as approved by the Ethical
Committee and is willing to comply with all protocol-required (follow-up)
evaluations.

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
endpoint;
6. Active pathological bleeding;
7. History of intracranial haemorrhage.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Primary Endpoint for this trial is a non-inferiority comparison of<br /><br>Patient-oriented Composite Endpoint (PoCE) at 12 months post-procedure. PoCE is<br /><br>a composite clinical endpoint of:<br /><br>* all-cause death;<br /><br>* any stroke, Modified Rankin scale, (MRS >=1);<br /><br>* any myocardial infarction (periprocedural MI according to SCAI, spontaneous<br /><br>according to 4th universal definition);<br /><br>* any clinically and physiologically driven revascularization.</p><br>

Secondary Outcome Measures