Clinical trial NCT01389531: Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
Official title: Evaluation of the Efficacy and Safety of the HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheobronchomalacia
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is, primarily, evaluate the safety of the use of the silicone stent HCPA-1 in patients with clinically significant tracheal and/or bronchial stenosis. Secondarily, this study aims to evaluate the efficacy of the use of the silicone stent HCPA-1 who are in the same conditions described above and also estimate the costs the use of these silicone stents involve.

Detailed description: * It is a prospective multicenter clinical study, not controlled, with evaluation of clinical variables before and after the intervention (insertion of one or more silicone stents in the trachea or bronchi and main or intermediate bronchus by rigid bronchoscopy under general anesthesia).
* 110 patients, both genders, will be followed for one year, total of 8 visits, in order to evaluate the safety of the procedure of stent insertion.

It is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement) - full anticoagulation or severe disturbance of coagulation. (Includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with INR\> 2.0 or aPTT \[KTTP\]\> 1.5 times control or platelet count \<50000). Note: The use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is allowed.

- The HCPA-1 silicone stent is made of biocompatible silicone, medical grade, via injection process in the matrix using different densities of the same material for a set of prostheses with rigid and flexible variables; available in the following dimensions (diameter x length in mm): 9x30, 9x50, 11x30, 11x50, 13x30, 13x50, 14x30, 14x50, 16x50, 16x70, 18x50 and 18x70. Requires specific surgical (applicator) for insertion.

Eligibility criteria: Inclusion Criteria:

* Consent to participate in the study by signing (the patient or family member/ legal guardian) of the Informed Consent Form;
* 18 years old or more;
* clinically significant stenosis (symptomatic or about to become symptomatic) for the trachea, main bronchus or intermediate bronchus, which can be treated with the stent implement.

Exclusion Criteria:

* clinical or absolute anesthesic contraindication of the rigid bronchoscopy under general anesthesia;
* constitutional or acquired anatomic limitations that prevent the rigid bronchoscopy;
* another indication of exclusive preferential treatment modality for stenosis (surgery, radiotherapy, chemotherapy, other). Note: It is allowed to include patients for whom it is indicated the combination of treatments (eg, electrocoagulation followed by stent placement);
* full anticoagulation or severe disturbance of coagulation. (Includes: use of any anticoagulant, by oral, intravenous or subcutaneous administration with full intention of coagulation / therapy; coagulopathy with INR\> 2.0 or aPTT \[KTTP\]\> 1.5 times control or platelet count \<50000). Note: The use of antiplatelet drugs (aspirin, clopidogrel, ticlopidine) is permitted.

Primary outcomes:
measure: Number of participants with adverse events as a measurement of Safety
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in Dyspnea using a Dyspnea score as a measurement of Efficacy
timeFrame: 1 year
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Hospital Universitario Getulio Vargas
state: Amazonas
city: Brasilia
country: Brazil
facility: Hospital Universitario de Brasilia
state: Distrito Federal
city: Goiania
country: Brazil
facility: Hospital das Clínicas de Goiania
state: Goias
city: Niteroi
country: Brazil
facility: Hospital Universitario Antonio Pedro
state: Rio de Janeiro
city: Natal
country: Brazil
facility: Centro de Ciencias da Saude
state: Rio Grande do Norte
city: Porto Alegre
country: Brazil
facility: HCPA Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
city: Rio de Janeiro
country: Brazil
facility: Hospital do Cancer I
city: Sao Paulo
country: Brazil
facility: Hospital Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Amarilio V Macedo, Postdoc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saueressig MG, Sanches PR, Macedo Neto AV, Moreschi AH, Oliveira HG, Xavier RG. Novel silicone stent to treat tracheobronchial lesions: results of 35 patients. Asian Cardiovasc Thorac Ann. 2010 Dec;18(6):521-8. doi: 10.1177/0218492310388428.