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

NARecruitingINTERVENTIONAL
Enrollment

546

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

January 1, 2026

Study Completion Date

January 1, 2028

Conditions
Coronary Artery Disease
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"

Trial Locations (14)

20521

NOT_YET_RECRUITING

Turku University Hospital, Turku

40620

NOT_YET_RECRUITING

Central Hospital of Central Finland, Jyväskylä

70210

NOT_YET_RECRUITING

Kuopio University Hospital, Kuopio

80210

RECRUITING

North Karelia Central Hospital, Joensuu

96400

NOT_YET_RECRUITING

Central Hospital of Lapland, Rovaniemi

00029

NOT_YET_RECRUITING

Helsinki University Hospital, Helsinki

Unknown

RECRUITING

Central Hospital of Päijät-Häme, Lahti

NOT_YET_RECRUITING

Oulu university hospital, Oulu

NOT_YET_RECRUITING

Satakunta Central Hospital, Pori

NOT_YET_RECRUITING

Tampere Heart Hospital, Tampere

NOT_YET_RECRUITING

Centre Hospitalier La Rochelle, La Rochelle

NOT_YET_RECRUITING

University Hospital of Carl Gustav Carus, Dresden

NOT_YET_RECRUITING

University Hospital of Saarland, Homburg

NOT_YET_RECRUITING

Norfolk and Norwich University Hospital Nhs Foundation Trust, Norwich

All Listed Sponsors
collaborator

Central Hospital of Lapland

UNKNOWN

collaborator

Kuopio University Hospital

OTHER

collaborator

Central Finland Hospital District

OTHER

collaborator

Helsinki University Central Hospital

OTHER

collaborator

Turku University Hospital

OTHER_GOV

collaborator

Oulu University Hospital

OTHER

collaborator

Tampere University Hospital

OTHER

collaborator

Satakunta Central Hospital

OTHER

collaborator

Päijät Häme Central Hospital

OTHER

collaborator

Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

collaborator

Centre Hospitalier de La Rochelle

OTHER

collaborator

Hospital Universitario de Cabuenes

OTHER

collaborator

University Hospital Carl Gustav Carus

OTHER

collaborator

University Hospital, Saarland

OTHER

lead

North Karelia Central Hospital

OTHER