Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Prior treatment

• Patients may be excluded if the disease can be managed by simply removing prior stents or performing more conservative therapies.

Other illness

• 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

Other

• Emergent/urgent clinically indicated stent.
• Chronic/permanent mechanical ventilation.
• Pure Excessive Dynamic Airway Collapse (EDAC) patients.
• Pure Pulmonary Resistance (Rp) patients.

• 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)