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

Last updated: October 26, 2023
Sponsor: National University of Ireland, Galway, Ireland
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myocardial Ischemia

Thrombosis

Cardiovascular Disease

Treatment

Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care

Clinical Study ID

NCT04923191
NUIG-2021-001
  • Ages > 18
  • All Genders

Study Summary

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 either angio-based physiology guidance angio-FFR (Quantitative Flow Ratio and coronary angiography-derived FFR, caFFR) or local routine diagnostic procedure (LRDP) and usual care. Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2*1270) patients. All patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (ASA) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). At 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.

Eligibility Criteria

Inclusion

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 anative coronary artery (with or without prior stent/other device treatment) or in asaphenous 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 visualassessment (no limitation on the number of treated lesions, vessels, or lesionlength);
  • Patient has been informed of the nature of the study and agrees to its provisions andhas provided written informed consent as approved by the Ethical Committee and iswilling to comply with all protocol-required (follow-up) evaluations.

Exclusion

Exclusion Criteria:

  1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performedwithin 7 days prior to the index procedure in women of child-bearing potentialaccording 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 platelettherapy (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.

Study Design

Total Participants: 2540
Treatment Group(s): 1
Primary Treatment: Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
Phase:
Study Start date:
November 12, 2021
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • ASZ Aalst

    Aalst,
    Belgium

    Active - Recruiting

  • OLVZ Aalst

    Aalst,
    Belgium

    Active - Recruiting

  • Imelda Ziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • Imeldaziekenhuis

    Bonheiden,
    Belgium

    Active - Recruiting

  • CHU Charleroi

    Charleroi,
    Belgium

    Active - Recruiting

  • Jessa Hospital Hasselt

    Hasselt,
    Belgium

    Active - Recruiting

  • University Hospital Galway

    Galway,
    Ireland

    Active - Recruiting

  • OLVG Amsterdam

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Medisch Spectrum Twente, Thoraxcentrum, Endchede

    Endchede,
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente, Thoraxcentrum, Endchede

    Enschede,
    Netherlands

    Active - Recruiting

  • UMC Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Den Haag Ziekenhuis

    Hague,
    Netherlands

    Active - Recruiting

  • Medisch Centrum Leeuwarden

    Leeuwarden,
    Netherlands

    Active - Recruiting

  • Maasstad Hospital

    Rotterdam,
    Netherlands

    Site Not Available

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Hospital Clínico de Barcelona

    Barcelona,
    Spain

    Active - Recruiting

  • Lucas Augusti Hospital

    Lugo,
    Spain

    Active - Recruiting

  • Hospital Clínico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Hospital Clínico Universitario of Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro Vigo

    Vigo,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro Vigo.

    Vigo,
    Spain

    Site Not Available

  • Barts Health NHS Trust, London

    London,
    United Kingdom

    Active - Recruiting

  • Freeman Hospital

    Newcastle,
    United Kingdom

    Active - Recruiting

  • University Hospitals Southampton

    Southampton,
    United Kingdom

    Active - Recruiting

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