The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an All-comers PCI Population With Unrestrictive Use of the HT Supreme Sirolimus-eluting Stent (PIONEER-IV)

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery disease, ischemia, quantitative flow ratio (QFR), P2Y12 monotherapy, drug-eluting stent, physiology guidance Read More

Inclusion Criteria:

• Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
• 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;
• 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);
• 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 (dual)anti platelet therapy (DAPT) 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.