Authorised Therapeutic use (Phase IV) Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Anticoagulant medicines for Balloon Pulmonary Angioplasty

Q: Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Q: Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

Q: How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Q: Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

EU CTIS ID: 2024-518803-23-00

What this study is testing

To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life- threatening or disabling bleeding, vascular injury or access site complications) and lung injury within 24 hours after BPA on a per-session basis.

Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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.

You likely can't join if

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 DOAC treatment: e.g. mechanical heart valves, myocardial thrombus, triple positive antiphospholipid syndrome, morbid obesity and (status after) bariatric treatment or major gastrointestinal resections and combination with CYP3A4 inhibitors and inductors. Anticoagulation dosage should be adjusted depending on renal function and drug interaction.
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.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.