Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive Read More

Inclusion Criteria: Patients will be considered for study inclusion if they have a clinical need for airway stenting defined by prior evidence of existing stents that have at least temporarily improved symptoms, but now suffer from stent complications; or those for whom a stent would be offered if an appropriate size and shape was available. Subjects must meet the following inclusion/exclusion criteria to be eligible for the study.

• Understand and voluntarily sign an informed consent form.
• Patients must be at least 22 years of age
• Patients must be able to undergo routine non-contrast CT scans of the chest
• Patient must be stable for general anesthesia and have an airway amenable to rigid bronchoscopy and stent implantation.
• The patients must have at least an expected 6 month survival.
• Patient must be able to maintain standard of care follow-up schedule and have access to standard of care medications and nebulizer machines and/or suction and oxygen as required for primary disease management.
• Patient must be able to personally provide consent and be able to describe Dyspnea and QOL and other patient-reported outcomes (PROs) required by study design
• Patient must require a stent that is within the design envelope of the patient-specific stents, as defined by COS (See Section 5.4 of this protocol for envelope)

Exclusion Criteria: Patients may be excluded if management of the airway problem can be safely and effectively treated with commercially available stents (SOC), non-stenting techniques, or surgical options.

• Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.
• Chronic anticoagulant therapy that could limit the safety of performing rigid therapeutic bronchoscopy in a timely manner. (I.e. Plavix within one year of drug eluding cardiac stent (DES) or 6 weeks following bare metal coronary stent)
• Unstable cardiac disease
• Allergy to silicone
• Stenting to manage vascular compression syndromes.
• Multi-drug resistant bacterial or fungal chronic infections
• Emergent/urgent clinically indicated stent.
• Chronic/permanent mechanical ventilation.
• Pure Excessive Dynamic Airway Collapse (EDAC) patients.
• Pure Pulmonary Resistance (Rp) patients.