Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Chronic Thromboembolic Disease (CTED) without Pulmonary Hypertension
Conditions
Brief summary
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 [2-3 and 5]) or lung injury (radiographic opacity with/without haemoptysis, with/without hypoxaemia) within 24 hours after BPA, on a per-session basis.
Detailed description
Individual items of the combined primary endpoint (on a per-session basis)., Procedure related endpoints (on a per-session basis): 1) Allergic reaction to contrast (assessed for total complication rate, not for VKA vs DOAC). 2) Renal dysfunction, Venous thromboembolism., Long-term bleeding complications based on international criteria., All-cause mortality., Non-scheduled hospitalization.
Interventions
DRUGAcenocoumarol CF 1 mg
DRUGtabletten
Sponsors
St. Antonius Ziekenhuis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
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 [2-3 and 5]) or lung injury (radiographic opacity with/without haemoptysis, with/without hypoxaemia) within 24 hours after BPA, on a per-session basis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual items of the combined primary endpoint (on a per-session basis)., Procedure related endpoints (on a per-session basis): 1) Allergic reaction to contrast (assessed for total complication rate, not for VKA vs DOAC). 2) Renal dysfunction, Venous thromboembolism., Long-term bleeding complications based on international criteria., All-cause mortality., Non-scheduled hospitalization. | — |
Countries
Netherlands
Outcome results
None listed