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Taking peoplePhase 4

Comparing two heart artery treatments in adults at high bleeding risk

Compares drug-coated balloons with drug-eluting stents in adults with heart artery disease.

Key facts

Who runs it
North Karelia Central Hospital
Where
Dresden and Homburg, GermanySee the 2 sitesAlso in 4 other countries, 11 sites
Registry title
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Status
Recruiting
Phase
Phase 4
People taking part
546 people, planned
Started
1 Sept 2022
Expected to end
1 Jan 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Percutaneous coronary intervention using drug-coated balloon
  • Percutaneous coronary intervention using drug-eluting stent
Record updated
9 November 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with stable coronary artery disease or acute coronary syndrome who have a high risk of bleeding and need a coronary stent or balloon procedure (PCI).

Age
18 years or older
Sex
All sexes can join.
Disease stage
Stable angina or shortness of breath with a narrowed coronary artery causing poor blood supply to the heart, or acute coronary syndrome (UAP or NSTEMI). New narrowings (de novo lesions) in the heart's own arteries or bypass vein grafts, vessel 2.0-5.0mm wide, narrowing up to 40mm long.
Earlier treatment
People who had a stent before need proof of poor blood supply (a perfusion scan or pressure wire test), unless the narrowing is over 90%.
Biomarker or test result
High-sensitivity troponin rise (in the acute coronary syndrome group). High bleeding risk: at least one major or two minor bleeding risk criteria, such as long-term blood thinner pills, kidney disease, low hemoglobin, or age over 75.

Main reasons for not taking part

  • STEMI (a certain type of heart attack)
  • Vessel narrower than 2.0mm or wider than 5.0mm
  • Re-narrowing inside an old stent, or a fully blocked artery (chronic total occlusion)
  • Life expectancy under 12 months, or cardiogenic shock
  • Cannot give written consent, or heart team decides bypass surgery is needed

The registry criteria, word for word

Show all 40 criteriaShow less

Who can take part

  • Age ≥ 18 years
  • Informed written consent
  • At least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC); Major Criteria
  • Long-term oral anticoagulation
  • Severe or end stage chronic kidney disease (CKD) (estimated glomerular - filtration rate [eGFR] <30 ml/min)
  • Hemoglobin <110 g/l
  • Spontaneous bleeding requiring hospitalization and transfusion in the past 6 months
  • Moderate to severe baseline thrombocytopenia (platelet count <100 x 10e9/L)
  • Chronic bleeding diathesis
  • Liver cirrhosis with portal hypertension
  • Active cancer in the past 12 months
  • Previous spontaneous ICH (at any time)
  • Previous traumatic ICH within the past 12 months
  • Presence of known brain arteriovenous malformation
  • Moderate to severe ischemic stroke within the past 6 months
  • Nondeferrable major surgery on dual antiplatelet therapy
  • Recent major surgery or trauma within 30 days before PCI; Minor Criteria
  • Age >75 years
  • Moderate CKD (eGFR 30-59 ml/min)
  • Hemoglobin 110-129 g/l for men and 110-119 g/l for women
  • Spontaneous bleeding requiring hospitalization or transfusion within the past 12 - months not meeting major criterion
  • Long term use of oral nonsteroidal antiinflammatory drugs or steroids
  • Any ischemic stroke at any time not meeting major criterion; 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

Who cannot take part

  • Need for bypass surgery by heart team decision
  • 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

Where in Germany

Also in 4 other countries, 11 sites

  • University Hospital of Carl Gustav CarusDresden, GermanyContact: Norman Manger, MD, PhDNot yet recruiting
  • UniversitY Hospital of SaarlandHomburg, GermanyContact: Bruno Scheller, MD, PhDNot yet recruiting

About the trial

What the trial wants to find out

The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to the treatment using DES and longer DAPT duration on patients with high bleeding risk. If non-inferiority is shown, the superiority of the DCB strategy over DES strategy will be tested.

The 2 groups in the trial

  • Drug-coated balloon (DCB)Treatment being tested

    The coronary lesions fulfilling the inclusion criteria and randomized to the DCB group.

    Treatment: Percutaneous coronary intervention using drug-coated balloon

  • Drug-eluting stent (DES)Existing treatment, for comparison

    The coronary lesions fulfilling the inclusion criteria and randomized to the DES group.

    Treatment: Percutaneous coronary intervention using drug-eluting stent

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Plain-language title
Comparing two heart artery treatments in adults at high bleeding riskGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
9 November 2023