International BPA Registry

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-000036
    NCT ID: NCT03245268
    Sponsor Protocol Number: 18-000036

About this study

The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Diagnosis with CTEPH according to the following criteria:

    • Mean PAP ≥ 25mmHg at rest; or if mean PAP < 25mmHg at rest, have exercise limitations from chronic thromboembolic disease
    • Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
  • Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
  • Naïve to BPA treatment
  • Scheduled to undergo their first BPA session ≥ 2 days after enrollment. The enrollment must occur before any BPA session
  • Willing to provide informed consent

Exclusion Criteria:

  • BPA treatment prior to enrollment
  • Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
  • Targeted BPA treatment lesion other than from WHO group IV (CTEPH)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Open for enrollment

Contact information:

Kristal Rohwer

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20411296

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