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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Where Is This Study? (3 UK sites)
Barts Health NHS Trust, London
London, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
University Hospitals Southampton
Southampton, United Kingdom
How to Get in Touch
Patrick W Serruys, MD
Sponsor contactCONTACT
Yoshinobu Onuma, MD
Sponsor contactCONTACT
