balloon pulmonalis angioplasty BPA
Conditions
Interventions
NOACs versus VKAs
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Established CTEPH or CTED diagnosis according to the guideline, with at least 3 months of anticoagulation treatment. - Inoperable patients, patients reluctant to undergo surgery or patients with residual PH after PEA and accepted for BPA treatment. - Accessible thromboembolic lesions for BPA.
Exclusion criteria
Exclusion criteria: - Operable CTEPH or CTED patients accepted for PEA. - Contra-indications for BPA: right-sided mechanical heart valve, thrombus or myxoma in the right atrium or right-sided valvular endocarditis. - Contra-indications for specific anticoagulation treatment: e.g. mechanical heart valves, myocardial thrombus. - High risk patients for bleeding complications: previous life-threatening bleeding (e.g. intracranial bleeding), age > 80 years or pulmonary vascular resistance > 10 woods units (WU). - Life-expectancy < 1 year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combination of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) based on the international criteria (PH-symposium, VARC and BARC) or lung injury within 24 hours after BPA, on a per-session basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints - Individual items of the combined primary endpoint (on a per-session basis). - Procedure related endpoints: (1) Allergic reaction to contrast and (2) renal dysfunction. - Venous thromboembolism. - Long-term bleeding complications based on international criteria. - All-cause mortality. - Non-scheduled hospitalization. Efficacy endpoints: - Functional class. - RV dimensions and function measured with MRI. - Cardiopulmonary exercise testing and 6-min walking distance. - Pulmonary hemodynamics (right atrial pressure, right ventricular pressure, pulmonary artery pressure, pulmonary artery wedge pressure, cardiac output, pulmonary vascular resistance). - Quality of life (CAMPHOR, EMPHASIS and EQ-5D-5L questionnaire). Coagulation endpoints: - Platelet activation by P-selectin - Coagulation as measured with multiple tests: *Fibrinolysis activity as measured with Plasmin-antiplasmin complex (PAP), D-dimers and TAFIa levels as well as in vitro clot-lysis time between the two drugs will be contrasted. *D-Dimers *Fibrin formation markers (fibrinopeptide A and B and soluble fibrin) - Overall thrombus formation and clot lysis assessment using Thromboelastography (TEG) and T-TAS | — |
Countries
Netherlands
Outcome results
None listed