Evaluating the Clinical Effectiveness of a Patient-specific Silicone Stent

Overview

About this study

The purpose of this study is to evaluate the clinical utility of a patient-specific silicone stent implant for patients with complex airway disease, requiring an airway stent. The aim of this study is to observe the outcomes associated with the implants. Current stents have been suboptimal for treating benign stenosis of the airway and we are seeking to create a better treatment option.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Eligibility last updated 11/4/21. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Ryan Kern, M.D.	Closed for enrollment	Contact information: Ryan Kern M.D. (800) 753-1606 Kern.Ryan@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ryan Kern, M.D.

Closed for enrollment

Contact information:

Ryan Kern M.D.

(800) 753-1606

Kern.Ryan@mayo.edu

More information

Publications

Airway self-expandable metallic stents (SEMS) were initially studied in malignant airway obstruction; however, their use in benign airway diseases has become progressively more frequent. This may be explained by their ease of insertion compared with silicone stents, which require rigid bronchoscopy for insertion. While initial experience with SEMS in benign disease suggested efficacy and promising short-term safety profile, long-term follow-up revealed significant complication rates. In addition to a high complication rate, the management of these complications is made more difficult by the semipermanent nature of these devices. Reported complications include infection, granulation tissue formation, stent migration, stent fracture, airway perforation and fistula formation, as well as extension of the initial injury, potentially eliminating other therapeutic options such as surgical resection. Therefore, SEMS should only be used in nonmalignant large airway disease as a last resort for patients in whom other endoscopic methods, including silicone stents and dilations, as well as surgical options have failed or are technically not feasible. Read More on PubMed
Respiratory tract infection with human papillomavirus has been associated with major airway complications, including tracheal stenosis. We report a case of recurrent respiratory papillomatosis infection complicated with iatrogenic airway fire injury causing airway stenosis. This was treated with reconstruction and a silicone Y stent placement. Three years after the stent placement, the patient presented with wheezing and shortness of breath. Bronchoscopy revealed tracheal narrowing proximal to the tracheal limb of the Y stent. The stenosis was treated with a stent intussusception technique with satisfactory results. Read More on PubMed
To highlight a potentially fatal complication of broncho-vascular fistula arising from the self expanding metallic stent (SEMS) placement. We retrospectively analyzed five patients with benign and malignant airway diseases, who developed tracheo/broncho-vascular fistulas following SEMS placement in our tertiary care setting. All patients received either Wallstent or Ultraflex(®) stent (Boston Scientific, Natick, MA) between 1999 and 2007. All patients had received adjunct therapy such as balloon bronchoplasty, laser therapy or electrocautery. Most patients presented with massive hemoptysis. A total of 483 SEMS were placed during this period. SEMS placement can be complicated by Broncho-vascular fistula formation. True incidence and precise time interval between the insertion of stent and onset of this complication is unknown. Additional therapeutic modalities to maintain stent patency may enhance the risk of fistula formation. SEMS should only be used in a select sub-group of patients, after exhaustive evaluation of other treatment options. These cases provide evidence that broncho-vascular fistulas can develop at any time following SEMS placement, suggesting the need for a more cautious approach, especially while using them for a long term management. In benign airway disease, the stent should be removed as soon as healing has taken place. Read More on PubMed
Airway anastomotic complications remain a major cause of morbidity and mortality after lung transplantation (LT). Few data are available with regard to the use of silicone stents for these airway disorders. The aim of this retrospective study was to evaluate the clinical efficacy and safety of silicone stents for such an indication. Read More on PubMed
Stents may be indicated as treatment of benign and malignant conditions of the central airways. Occasionally, aberrant and/or distorted airways secondary to therapy or surgery may preclude the use of commercially manufactured stents. The customization of stents is well described for nonpulmonary diseases, but to date there are only limited data in the literature on prosthesis customization for airway disease. Read More on PubMed
Benign endobronchial granulation tissue causes airway obstruction in up to 20% of patients after lung transplantation or stent placement. High-dose-rate endobronchial brachytherapy (HDR-EB) has been successful in some cases refractory to standard bronchoscopic interventions. Read More on PubMed
The Polyflex stent (Boston Scientific; Boston, MA) is a self-expanding, thin-walled, silicone stent. Its use has been described in the management of patients with malignant airway obstruction, yet reports of its use for treatment of benign airway conditions are rare. Read More on PubMed
s: To report and analyze our 6-year experience with implanting 112 self-expandable metallic stents (SEMSs) using flexible bronchoscopy (FB). Read More on PubMed

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