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Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI (DEBATE)
EU CTIS ID: 2023-504340-34-01
What this study is testing
The purpose of this study is to compare percutaneous coronary intervention using drug-coated balloon (DCB) with drug-eluting stents (DES) in stable coronary artery disease (CAD) or in acute coronary syndromes (ACS) in patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter dual-antiplatelet (DAPT) treatment is non-inferior to the treatment using DES and longer DAPT duration in patients with high bleeding risk.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years, informed written consent, at least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC). Either of the following: Stabile angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram. In stable patients prior PCI, the evidence of ischemia is needed acquired either by perfusion imaging or by pressure wire measurement (FFR) during coronary angiography unless the coronary stenosis is > 90% in diameter. ACS (UAP or NSTEMI): symptoms of heart ischemia≥ 20 minutes and ≥ 0,5mm ST-depression or transient ST-elevation or T-wave inversion at least in two adjacent leads and/or a high sensitivity troponin (hs-tnt) rise at least one unit above the 99. percentil or at least 50% rise in hs-tnt between two samples taken 1-3 hours apart. At least one of the following: ≥1 de novo lesions in native coronary arteries or bypass vein grafts. Reference diameter of the vessel is 2.0-5.0mm. Lesion length ≤ 40mm. Lesion or lesions are suitable for PCI.
You likely can't join if
- Inability to give written consent STEMI. Reference diameter of the vessel is <2.0mm or >5.0 mm. Bifurcation lesion requiring the stenting of either of the branches after predilatation. (TIMI<3 or significant recoil >30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation). Dissection affecting the flow (TIMI<3) or significant recoil (>30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation. In-stent restenosis. Chronic total occlusion. Life expectancy < 12 months. Cardiogenic shock at the arrival to the coronary angiography. Uncertainty about neurological recovery e.g. after resuscitation. Need for bypass surgery by heart team decision.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.