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)

October 26, 2023 updated by: Patrick Serruys, National University of Ireland, Galway, Ireland

Non-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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2540

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Aalst, Belgium
        • Recruiting
        • OLVZ Aalst
        • Principal Investigator:
          • Jeroen Sonck
      • Aalst, Belgium
        • Recruiting
        • ASZ Aalst
        • Principal Investigator:
          • Liesbeth Rosseel, MD
      • Bonheiden, Belgium
        • Recruiting
        • Imelda Ziekenhuis
        • Principal Investigator:
          • Kenneth De Wilder
      • Charleroi, Belgium
        • Recruiting
        • CHU Charleroi
        • Principal Investigator:
          • Adel Aminian
      • Hasselt, Belgium
        • Recruiting
        • Jessa Hospital Hasselt
        • Principal Investigator:
          • Edouard Benit
  • Ireland
      • Galway, Ireland
        • Recruiting
        • University Hospital Galway
        • Contact:
          • Faisal Sharif, MD
  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • OLVG Amsterdam
        • Principal Investigator:
          • Giovanni Amoroso
      • Enschede, Netherlands
        • Recruiting
        • Medisch Spectrum Twente, Thoraxcentrum, Endchede
        • Principal Investigator:
          • Clemens Von Birgelen
      • Groningen, Netherlands
        • Recruiting
        • UMC Groningen
        • Principal Investigator:
          • Joanna Wykrzykowska, MD PhD
      • Hague, Netherlands
        • Recruiting
        • Den Haag Ziekenhuis
        • Principal Investigator:
          • Samer Somi
      • Leeuwarden, Netherlands
        • Recruiting
        • Medisch Centrum Leeuwarden
        • Principal Investigator:
          • Sjoerd Hofma
      • Rotterdam, Netherlands
        • Recruiting
        • Maasstad Ziekenhuis
        • Principal Investigator:
          • Valeria Paradies
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Clínico de Barcelona
        • Principal Investigator:
          • Manel Sabate
      • Lugo, Spain
        • Recruiting
        • Lucas Augusti Hospital
        • Principal Investigator:
          • Raymundo Ocaranza
      • Valladolid, Spain
        • Recruiting
        • Hospital Clínico Universitario of Valladolid
        • Principal Investigator:
          • Ignacio J Amat-Santos
      • Vigo, Spain
        • Recruiting
        • Hospital Alvaro Cunqueiro Vigo
        • Principal Investigator:
          • Victor Alfonso Jimenez Diaz
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Barts Health NHS Trust, London
        • Contact:
          • Andreas Baumbach, MD
      • Newcastle, United Kingdom
        • Recruiting
        • Freeman Hospital
        • Principal Investigator:
          • Mohammad Alkhalil
      • Southampton, United Kingdom
        • Recruiting
        • University Hospitals Southampton
        • Principal Investigator:
          • Nick Curzen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Local routine diagnostic procedure (LRDP) and usual care
Other: Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention
Other: Angiography-derived Physiology Guidance: angio-FFR (QFR and caFFR)
Quantitative Flow Ratio- QFR, Coronary angiography-derived FFR - caFFR
Other: Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care
percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented Composite Endpoint (PoCE)
Time Frame: 12 months

PoCE is a composite clinical endpoint of:

  • all-cause death;
  • any stroke, Modified Rankin scale, (MRS ≥1);
  • any myocardial infarction;
  • any clinically and physiologically driven revascularization.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vessel-oriented composite endpoints (VoCE)
Time Frame: 12, 24 and 36 months

VoCE is a composite clinical endpoint of:

  • Vessel-related cardiovascular Death
  • Target-vessel related MI
  • Clinically and physiologically-oriented Target vessel revascularization
12, 24 and 36 months
Device-oriented composite endpoint (DoCE)
Time Frame: 12, 24 and 36 months

DoCE is a composite endpoint of:

  • Cardiovascular Death
  • Target-vessel related MI
  • Clinically and physiologically-oriented Target lesion revascularization
12, 24 and 36 months
Myocardial Infarction (MI)
Time Frame: 48 hours post-procedure
Peri-procedure Myocardial Infarction according to 4th universal definition
48 hours post-procedure
Device Success Rate
Time Frame: index procedure
according to the statement from European Association of Percutaneous Cardiovascular Interventions (EAPCI) of the European Society of Cardiology (ESC)
index procedure
Stent Thrombosis
Time Frame: Procedure, 12, 24 and 36 months
Definite, Probable, Definite or Probable
Procedure, 12, 24 and 36 months
Target Vessel Failure (TVF)
Time Frame: 12, 24 and 36 months

TVF is a composite of:

  • Cardiovascular Death
  • Target-vessel related MI
  • Clinically and physiologically-oriented Target vessel revascularization
12, 24 and 36 months
Bleeding
Time Frame: 12, 24 and 36 months follow-up
Bleeding according to Bleeding Academic Research Consortium (BARC) (BARC 2, 3 and 5) classification
12, 24 and 36 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Ireland, Galway, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2021

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NUIG-2021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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