Airway Segmented Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Distal Bronchi

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03890575
• Collaborator: Shanghai Pulmonary Hospital, Shanghai, China (Other), Shanghai Tong Ren Hospital (Other), Ruijin Hospital Luwan Branch (Other)
• Enrollment: 100
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 69
• Patients Per Site: 50
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.

Condition or Disease	Intervention/Treatment	Phase
Stricture; Trachea; Malignant Neoplasm	Procedure: Airway stent implantation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
• Actual Study Start Date: Apr 1, 2017
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Airway Stent for Malignant Stricture Patients with malignant stricture were implanted with covered metallic segmented stent modified with 3D printing.	Procedure: Airway stent implantation; The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.

Outcome Measures

Primary Outcome Measures

1. Improvement in Dyspnea using Hugh-Jones classication as criteria [3 days]

   Hugh-Jones classication: dyspnea scale that includes 5 categories.

2. Stent patency time [2 months]

   Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive.

3. Overall survival [6 months]

   OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.

Secondary Outcome Measures

1. Number of participants with adverse events that are related to stent implantation [2 months]

   Adverse events as follows: migration of the stent, severe chest pain, hemoptysis, granuloma formation, pneumonia and accumulation of secretion

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.

Exclusion Criteria:

• Severe infection

• Coagulation disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin Hospital Luwan Branch	Shanghai		China
2	Shanghai Tongren Hospital	Shanghai		China

Sponsors and Collaborators

• Ruijin Hospital
• Shanghai Pulmonary Hospital, Shanghai, China
• Shanghai Tong Ren Hospital
• Ruijin Hospital Luwan Branch

Investigators

• Principal Investigator: Zhongmin Wang, MD, Ruijin Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhongmin Wang, Principal Investigator, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT03890575
• Other Study ID Numbers: malignantairwaystent
• First Posted: Mar 26, 2019
• Last Update Posted: Feb 11, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhongmin Wang, Principal Investigator, Ruijin Hospital: 3D printed; airway stent; carina; distal bronchi
• Additional relevant MeSH terms: Neoplasms; Tracheal Stenosis; Constriction, Pathologic

Study Results

No Results Posted as of Feb 11, 2020