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Clinical Trials in France / NCT04814212
Recruiting Not applicable

Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI

NCT04814212 · tracked via the Priya Life Science France tracker
Sponsor
North Karelia Central Hospital
Phase
Not applicable
Started
2022-09-01
Last updated
2023-11-09

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Percutaneous coronary intervention using drug-coated balloonPercutaneous coronary intervention using drug-eluting stent

Percutaneous coronary intervention using drug-coated balloon: SeQuent Please (BBraun) + tailored antithrombotic regimen: 1. Stable patients without OAC: perioperative SAPT (preferably) or perioperative DAPT followed by lifelong SAPT 2. Stable patients with OAC: perioperative SAPT (preferably) or perioperative DAPT and lifelong OAC 3. ACS patients without OAC: 1-month DAPT followed by lifelong SAPT 4. ACS patients with OAC: perioperative DAPT followed by 1-month SAPT and lifelong OAC

Percutaneous coronary intervention using drug-eluting stent: Biofreedom (Biosensors), Synergy (Boston Scientific), Ultimaster Tansei (Terumo) and Integrity Onyx (Medtronic), Xience Pro S (Abbott) or Promus Elite (Boston Scientific) or any other DES can also be used provided that it has a CE mark for 1-month DAPT, combined with tailored antithrombotic regimen: 1. Stable patients without OAC: 1-month DAPT followed by lifelong SAPT 2. Stable patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and life-long OAC 3. ACS patients without OAC: 3-month DAPT followed by lifelong SAPT 4. ACS patients with OAC: perioperative DAPT followed by 6 months SAPT (ADP receptor blocker) and lifelong OAC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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: 1. 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. 2. 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Central Hospital of Central Finland Jyväskylä Central Finland Not Yet Recruiting
Central Hospital of Lapland Rovaniemi Lapland Not Yet Recruiting
Kuopio University Hospital Kuopio Northern Savonia Not Yet Recruiting
Turku University Hospital Turku Southwest Finland Not Yet Recruiting
Helsinki University Hospital Helsinki Uusimaa Not Yet Recruiting
North Karelia Central Hospital Joensuu Finland Recruiting
Central Hospital of Päijät-Häme Lahti Finland Recruiting
Oulu university hospital Oulu Finland Not Yet Recruiting
Satakunta Central Hospital Pori Finland Not Yet Recruiting
Tampere Heart Hospital Tampere Finland Not Yet Recruiting
Centre Hospitalier La Rochelle La Rochelle France Not Yet Recruiting
University Hospital of Carl Gustav Carus Dresden Germany Not Yet Recruiting
University Hospital of Saarland Homburg Germany Not Yet Recruiting
Norfolk and Norwich University Hospital Nhs Foundation Trust Norwich United Kingdom Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04814212 on ClinicalTrials.gov ↗ ← All trials in France