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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2540

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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