International BPA Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 18
- 主要终点
- Safety as assessed by BPA-associated complications
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Safety as assessed by BPA-associated complications
时间窗: Min. 2 years
Efficacy as assessed by change in mPAP
时间窗: Min. 2 years
Change in mean pulmonary arterial pressure (mPAP) from baseline to latest post-interventional follow-up hemodynamics
Efficacy as assessed by change in PVR
时间窗: Min. 2 years
Change in pulmonary vascular resistance (PVR) from baseline to latest post-interventional follow-up hemodynamics
次要结局
- At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals(Min. 2 years)
- Analyze patient selection criteria for BPA across sites at the end of recruitment(Min. 2 years)
- Health care resource use required to complete BPA(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up(Min. 2 years)
- Analyze the impact of PH targeted medical treatment on key patient outcomes(Min. 2 years)
- Compare volume of BPA cases across regions and case load at the end of recruitment(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up(Min. 2 years)
- At the end of follow-up, compare technical aspects of BPA as assessed by technical limits(Min. 2 years)
- Analyze the use of PH targeted medical therapy after BPA(Min. 2 years)
- Analyze the use of PH targeted medical therapy before BPA(Min. 2 years)