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RECRUITING
NCT04814212
NA

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

Sponsor: North Karelia Central Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

546

Start Date

2022-09-01

Completion Date

2028-01-01

Last Updated

2023-11-09

Healthy Volunteers

No

Interventions

DEVICE

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

DEVICE

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

Locations (14)

Central Hospital of Central Finland

Jyväskylä, Central Finland, Finland

Central Hospital of Lapland

Rovaniemi, Lapland, Finland

Kuopio University Hospital

Kuopio, Northern Savonia, Finland

Turku University Hospital

Turku, Southwest Finland, Finland

Helsinki University Hospital

Helsinki, Uusimaa, Finland

North Karelia Central Hospital

Joensuu, Finland

Central Hospital of Päijät-Häme

Lahti, Finland

Oulu university hospital

Oulu, Finland

Satakunta Central Hospital

Pori, Finland

Tampere Heart Hospital

Tampere, Finland

Centre Hospitalier La Rochelle

La Rochelle, France

University Hospital of Carl Gustav Carus

Dresden, Germany

University Hospital of Saarland

Homburg, Germany

Norfolk and Norwich University Hospital Nhs Foundation Trust

Norwich, United Kingdom