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

Phase 1

Conditions: Coronary artery disease
MedDRA version: 20.0Level: PTClassification code: 10011078Term: Coronary artery disease Class: 100000004849
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: CTIS2023-504340-34-01

Lead Sponsor: Wellbeing Services County Of North Karelia Siun Sote

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 534

Inclusion Criteria

Age = 18 years, informed written consent, at least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC). 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 Criteria

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.