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Clinical study on optimization of balloon pulmonary angioplasty technique and methodology

Clinical study on optimization of balloon pulmonary angioplasty technique and methodology

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037089
Enrollment
Unknown
Registered
2020-08-26
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic thromboembolic pulmonary hypertension

Interventions

Interventions:Balloon pulmonary angioplasty

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as CTEPH according to the Chinese guidelines for diagnosis and treatment of pulmonary hypertension (2018 Edition) (1) There were chronic thromboembolic diseases with mean Pap >= 25mmhg in resting state or less than 25mmhg in resting state; (2) Pulmonary ventilation perfusion (VQ) scan pulmonary angiography, computed tomography (CT) pulmonary angiography or magnetic resonance pulmonary angiography (MRPA) confirmed chronic thromboembolic diseases according to diagnostic criteria; 2. Patients who received anticoagulant therapy for more than 3 months before the diagnosis of CTEPH; 3. Patients with CTEPH who are unable to perform pea because of contraindications, have high surgical risk or are unwilling to take pea.

Exclusion criteria

Exclusion criteria: 1. Clinical diagnosis: (1) Pulmonary hypertension caused by other causes other than chronic thromboembolic pulmonary hypertension (CTEPH). (2) At present, there are active infection and sepsis. (3) Hemorrhagic disease, unhealed ulcer. (4) Patients with severe complications, such as liver disease, kidney disease, bleeding tendency, and poorly controlled diabetes and hypertension. (5) The life expectancy is less than 2 years. 2. Laboratory inspection (1) Hematological abnormalities (WBC < 3 x 10^9 / L, acute anemia HB < 90g/L, platelet count < 50 x 10^9). (2) Renal failure (EGFR < 30ml / min * 1.73m ^ 2) and / or advanced renal disease require renal dialysis. (3) Serious infectious diseases. (4) Severe bleeding tendency. 3. Device related (1) Allergy or contraindication to nitinol, iodine contrast agent, aspirin, clopidogrel and heparin. (2) Pregnancy, lactation or planned pregnancy during the trial. (3) The researcher judged that the patient's compliance was poor and could not complete the study according to the requirements.

Design outcomes

Primary

MeasureTime frame
mean pulmonary artery pressure;pulmonary vascular resistance;

Countries

China

Contacts

Public ContactDachun Xu

Shanghai Tenth People's Hospital

xdc77@tongji.edu.cn+86 21-66308182

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026