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International BPA Registry

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ClinicalTrials.gov Identifier: NCT03245268
Recruitment Status : Recruiting
First Posted : August 10, 2017
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
International CTEPH Association

Brief Summary:
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).

Condition or disease Intervention/treatment
Chronic Thromboembolic Pulmonary Hypertension CTEPH Procedure: Balloon pulmonary angioplasty

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: International BPA Registry
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : March 2, 2022
Estimated Study Completion Date : March 2, 2022



Intervention Details:
  • Procedure: Balloon pulmonary angioplasty
    BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
    Other Name: BPA


Primary Outcome Measures :
  1. Safety as assessed by BPA-associated complications [ Time Frame: Min. 2 years ]
  2. Efficacy as assessed by change in PVR [ Time Frame: Min. 2 years ]
    Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics

  3. Efficacy as assessed by change in mPAP [ Time Frame: Min. 2 years ]
    Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics


Secondary Outcome Measures :
  1. Compare volume of BPA cases across regions and case load at the end of recruitment [ Time Frame: Min. 2 years ]
  2. Analyze patient selection criteria for BPA across sites at the end of recruitment [ Time Frame: Min. 2 years ]
  3. At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites [ Time Frame: Min. 2 years ]
    Imaging modalities encompass VQ scan, selective pulmonary angiogram, CT pulmonary angiogram, dual-energy CT, cone-beam CT, MRI, OCT and IVUS

  4. At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals [ Time Frame: Min. 2 years ]
  5. At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up [ Time Frame: Min. 2 years ]
  6. At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up [ Time Frame: Min. 2 years ]
  7. At the end of follow-up, compare technical aspects of BPA as assessed by technical limits [ Time Frame: Min. 2 years ]
  8. Analyze the use of PH targeted medical therapy before BPA [ Time Frame: Min. 2 years ]
    PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other

  9. Analyze the use of PH targeted medical therapy after BPA [ Time Frame: Min. 2 years ]
    PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other

  10. Analyze the impact of PH targeted medical treatment on key patient outcomes [ Time Frame: Min. 2 years ]
    PH targeted therapy will be categorised as prostacyclin, IP agonist, PDE5 inhibitor, ERA, guanylate cyclase stimulator and other Key patient outcomes encompass WHO functional class, 6-minute-walk-distance, Borg dyspnoe score, haemodynamics and mortality

  11. Health care resource use required to complete BPA [ Time Frame: Min. 2 years ]
    As assessed by total hospital days in/out



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with CTEPH meeting the inclusion criteria listed below and scheduled to undergo BPA intervention are eligible for inclusion into the International BPA Registry.
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 ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245268


Contacts
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Contact: Fabrizio Canonaco, Dr + 41 41 379 79 70 fabrizio.canonaco@cteph-association.org
Contact: Simone Lerch, Dr + 41 41 379 79 70 simone.lerch@cteph-association.org

Locations
Show Show 18 study locations
Sponsors and Collaborators
International CTEPH Association
Investigators
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Principal Investigator: Nick H Kim, Prof International CTEPH Association
Additional Information:
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Responsible Party: International CTEPH Association
ClinicalTrials.gov Identifier: NCT03245268    
Other Study ID Numbers: BPA Registry
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International CTEPH Association:
Balloon pulmonary angioplasty
BPA
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases