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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

Sponsor: National University of Ireland, Galway, Ireland

NCT ID: NCT04923191

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care (other)
How long the study runs
Study runs about 86 months (dates as stated)
About the drug or intervention
Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care — other: percutaneous coronary intervention
Patient visit burden
Not specified by the sponsor

In plain English

This study, called PIONEER-IV, is looking at people with coronary artery disease (narrowing of the heart's blood vessels) who are having a procedure called PCI (percutaneous coronary intervention) to place a stent. It compares two approaches: guiding decisions using a test called angiography-derived physiology (which assesses how severely a vessel is narrowed) versus the usual care doctors normally provide. Everyone in the study receives the same type of stent, called the HT Supreme sirolimus-eluting stent.

Who can take part

  • Has chronic stable angina (chest pain caused by reduced blood flow to the heart), an acute coronary syndrome (a sudden heart blood flow problem), or silent ischemia (reduced blood flow without symptoms)
  • Has one or more narrowings of at least 50% in a heart artery or a bypass graft, suitable for stent placement
  • The blood vessel is wide enough (at least 2.25 mm by visual check) — there is no limit on the number of blockages treated, vessels involved, or length of the blockages
  • Has been told about the study, agrees to take part, gives written informed consent, and is willing to attend all required follow-up checks

Who may not be able to

  • Women who are pregnant or breastfeeding
  • Known allergy or bad reaction to cobalt chromium, or to medicines such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors (blood-thinning medicines)
  • Planning major planned surgery within 12 months that would mean stopping blood-thinning medicines
  • Another medical condition giving a life expectancy of less than 3 years
  • Currently taking part in another trial that has not yet reached its main endpoint
  • Active abnormal bleeding
  • Past bleeding inside the skull (intracranial haemorrhage)

What taking part involves

  • • A PCI procedure to place a heart stent (the HT Supreme sirolimus-eluting stent)
  • • Being assigned to either guidance based on an angiography-derived physiology test or usual care
  • • Follow-up evaluations as required by the study

Time commitment: Not stated — ask the trial team. Taking part involves the stent procedure, follow-up checks, and written informed consent.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
2,540
Started
2021-11-12
Last checked
2023-10

Plain English Summary

What is this study?

  • • Testing a new treatment for coronary artery disease
  • • NA - 2,540 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with coronary artery disease

Where?

  • • London - Barts Health NHS Trust, London
  • • Newcastle - Freeman Hospital
  • • Southampton - University Hospitals Southampton

This is a simplified summary. Always discuss with your doctor before making any decisions.

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 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.

Coronary Artery Disease

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ (follow-up) evaluations

What the study is looking for

  • ✓Patient has chronic stable angina, acute coronary syndromes or silent ischemia;
  • ✓The vessel should have a reference vessel diameter of at least 2.25 mm by visual assessment (no limitation on the...

Who cannot take part

  • ✗Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index...
  • ✗Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12...
  • ✗Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of...
  • ✗Concurrent medical condition with a life expectancy of less than 3 years;
  • ✗Currently participating in another trial and not yet at its primary endpoint;
See the full 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 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.

Where Is This Study? (3 UK sites)

Barts Health NHS Trust, London

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mays Jawad

research.governance@qmul.ac.uk020 7882 6826

Freeman Hospital

Newcastle, United Kingdom

Recruiting
Site contact (verified)
Mohammad AlkhalilPrincipal Investigator

University Hospitals Southampton

Southampton, United Kingdom

Recruiting
Site contact (verified)
Nick CurzenPrincipal Investigator

How to Get in Touch

Patrick W Serruys, MD

Sponsor contact

CONTACT

+31622924061 Patrick.Serruys@universityofgalway.ie

Yoshinobu Onuma, MD

Sponsor contact

CONTACT

+353852882318 Yoshinobu.Onuma@universityofgalway.ie
Data sourced from ClinicalTrials.gov · Last verified: 2023-10