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Compares treatment options for Coronary Artery Disease
Official title 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
ClinicalTrials.gov ID: NCT04923191
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
- Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;
- Concurrent medical condition with a life expectancy of less than 3 years;
- Currently participating in another trial and not yet at its primary endpoint;
- Active pathological bleeding;
See the full eligibility 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...
- 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...
- 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);
- Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;
- Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;
- Concurrent medical condition with a life expectancy of less than 3 years;
- Currently participating in another trial and not yet at its primary endpoint;
- Active pathological bleeding;
- History of intracranial haemorrhage.
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Bonheiden, Belgium
- Charleroi, Belgium
- Hasselt, Belgium
- Galway, Ireland
- Amsterdam, Netherlands
- Enschede, Netherlands
- Groningen, Netherlands
- Leeuwarden, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Barcelona, Spain
- Lugo, Spain
- Valladolid, Spain
- Vigo, Spain
- London, United Kingdom
- Newcastle, United Kingdom
- Southampton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Bonheiden, Belgium; Charleroi, Belgium; Hasselt, Belgium; Galway, Ireland; Amsterdam, Netherlands and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.