Anticoagulant medicines for Balloon Pulmonary Angioplasty

Phase 4

Recruiting

• Conditions: balloon pulmonalis angioplasty; 10019280; 10037454; BPA

• Registration Number: NL-OMON53991
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 84

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Combination of periprocedural bleeding (life-threatening or disabling bleeding,<br /><br>vascular injury or access site problems) based on the international criteria<br /><br>(PH-symposium, VARC and BARC) or lung injury within 24 hours after BPA, on a<br /><br>per-session basis.</p><br>