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

Recruiting N/A Interventional Study
Coronary Artery Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
2,540 (estimated)
Sponsor
National University of Ireland, Galway, Ireland · Other
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About This Trial
PIONEER-IV is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to LRDP and usual care in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent. Patients will be randomized to ei…
Trial Locations
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Eligibility Criteria
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 arteri…
Contacts

Patrick W Serruys, MD

+31622924061

Patrick.Serruys@universityofgalway.ie

CONTACT

Yoshinobu Onuma, MD

+353852882318

Yoshinobu.Onuma@universityofgalway.ie

CONTACT