Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04814212

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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:

  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
Not Eligible

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

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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

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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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