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Multicenter, Randomized, Case-control Clinical Study on the Effect of Treating Benign Tracheal Stenosis and Long-term Implantation Safety of Two Types of Tracheal Stent

Multicenter, Randomized, Case-control Clinical Study on the Effect of Treating Benign Tracheal Stenosis and Long-term Implantation Safety of Two Types of Tracheal Stent

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-15007462
Enrollment
Unknown
Registered
2015-11-26
Start date
2015-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Benign Tracheal Stenosis

Interventions

Group B:nitinol mesh stent (Mivto-tech, Nanjing)

Sponsors

China Meitan General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18; 2. Large airway stenosis: patients of tracheal stenosis scar, tracheomalacia, tracheal collapse, etc. caused by tuberculosis, endotracheal intubation or tracheotomy after surgery or trauma who need the placement of trachea or bronchial stent; 3. Airway stenosis more than 50%; 4. more than 3 months expected lifetime; 5. understand the study and sign the Informed Consent Form.

Exclusion criteria

Exclusion criteria: 1. tracheal stenosis caused by endobronchial tumor; 2. with complications of tracheal fistula; 3. bronchial stenosis (stenosis located at V, VI, VII, VIII); 4. severe arrhythmia, acute myocardial ischemia, uncontrolled hypertension crisis; 5. coagulopathy (PT time> 2 times the upper limit of normal or PLT <50*10^9/L); 6. severe organ dysfunction (including shock, severe liver and kidney dysfunction, upper gastrointestinal bleeding, DIC, hemoptysis, etc.); 7. allergic to anesthetics; 8. refused to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
polypnea rating;imaging examination;Degree of stenosis relief: (completely, partially, minor, invalid);

Secondary

MeasureTime frame
Karnofsky Physical scales of patients;Lung function;6-minute walk test;bronchoscopy;

Countries

CHINA

Contacts

Public ContactWang Hongwu
wanghongwu2008@aliyun.com+86 13910596991

Outcome results

None listed

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