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Status:

RECRUITING

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

Lead Sponsor:

North Karelia Central Hospital

Collaborating Sponsors:

Central Hospital of Lapland

Kuopio University Hospital

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 DAP...

Detailed Description

Implantation of a drug-eluting stent (DES) has become a standard of percutaneous coronary intervention (PCI) during the last two decades. However there are still significant drawbacks in using DES as ...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2028

Estimated Enrollment :

546 Patients enrolled

Trial Details

Trial ID

NCT04814212

Start Date

September 1 2022

End Date

January 1 2028

Last Update

November 9 2023

Active Locations (14)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 4 (14 locations)

1

Central Hospital of Central Finland

Jyväskylä, Central Finland, Finland, 40620

2

Central Hospital of Lapland

Rovaniemi, Lapland, Finland, 96400

3

Kuopio University Hospital

Kuopio, Northern Savonia, Finland, 70210

4

Turku University Hospital

Turku, Southwest Finland, Finland, 20521