Actively Recruiting
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Led by North Karelia Central Hospital · Updated on 2023-11-09
546
Participants Needed
14
Research Sites
278 weeks
Total Duration
On this page
Sponsors
N
North Karelia Central Hospital
Lead Sponsor
C
Central Hospital of Lapland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Central Hospital of Central Finland
Jyväskylä, Central Finland, Finland, 40620
Not Yet Recruiting
2
Central Hospital of Lapland
Rovaniemi, Lapland, Finland, 96400
Not Yet Recruiting
3
Kuopio University Hospital
Kuopio, Northern Savonia, Finland, 70210
Not Yet Recruiting
4
Turku University Hospital
Turku, Southwest Finland, Finland, 20521
Not Yet Recruiting
5
Helsinki University Hospital
Helsinki, Uusimaa, Finland, 00029
Not Yet Recruiting
6
North Karelia Central Hospital
Joensuu, Finland, 80210
Actively Recruiting
7
Central Hospital of Päijät-Häme
Lahti, Finland
Actively Recruiting
8
Oulu university hospital
Oulu, Finland
Not Yet Recruiting
9
Satakunta Central Hospital
Pori, Finland
Not Yet Recruiting
10
Tampere Heart Hospital
Tampere, Finland
Not Yet Recruiting
11
Centre Hospitalier La Rochelle
La Rochelle, France
Not Yet Recruiting
12
University Hospital of Carl Gustav Carus
Dresden, Germany
Not Yet Recruiting
13
University Hospital of Saarland
Homburg, Germany
Not Yet Recruiting
14
Norfolk and Norwich University Hospital Nhs Foundation Trust
Norwich, United Kingdom
Not Yet Recruiting
Research Team
T
Tuomas Rissanen, MD, PhD
CONTACT
A
Alma Räsänen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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