- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05895305
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis
May 31, 2023 updated by: Airiver Medical, Inc.
Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)
The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Benign central airway stenosis/obstruction, including stenosis of the subglottic area, trachea, and bronchi, is related to significant morbidity due to dyspnea and impaired quality of life.
It is hypothesized that Airiver pulmonary drug-coated balloon (DCB) will improve patient outcome in the bronchoscopic treatment of benign airway obstruction, and, as an adjunct to standard of care, will prolong airway patency compared to the standard of care alone.
This is a prospective, multi-center, single-arm, open-label, safety & feasibility, OUS first in human study for safety and potential efficacy.
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yan Li, MD
- Phone Number: 6513530685
- Email: liy@airiver.com
Study Contact Backup
- Name: Mitch Erickson
- Phone Number: 6518954399
- Email: ericksonm@airiver.com
Study Locations
-
-
-
Tbilisi, Georgia, 0101
- Recruiting
- Tbilisi State Medical University
-
Contact:
- Kakha Vacharadze, MD
- Phone Number: 995-599-557576
- Email: kakhavacharadze@yahoo.com
-
Contact:
- Tornike Jashi
- Email: jashitornike@gmial.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 old
Symptomatic, severe (> 50%) benign CAO (by CT or bronchoscopy)
- Stenosis is distal to cricoid and proximal to segmental bronchi
- Indicated for balloon dilation only or as an adjunct to standard of care
Includes, but not limited to :
- Post intubation tracheal stenosis (PITS)
- Post tracheostomy tracheal stenosis (PTTS)
- Post lung transplantation stenosis
- Stenosis related to airway stent
- Subglottic stenosis (SGS)
- Stenosis due to tuberculosis
Exclusion Criteria:
- Malignant CAO
- Dynamic etiology of benign stenosis such as excessive dynamic airway collapse, tracheobronchomalacia, or stenosis due to external compression
- Presence of a known perforation at the site of proposed dilation
- Presence of a known fistula between the tracheobronchial tree and esophagus, mediastinum to pleural space
- Obstruction not amenable to bronchoscopic dilation in the opinion of the investigator
- Allergy to paclitaxel or structurally related compounds
- Severe coagulation disorders or current use of anticoagulant or antiplatelet medication that cannot be safely managed per recommended guidelines prior to the index procedure
- Acute stricture condition that requires emergent procedure (e.g., immediate dilation)
- Vasculitis that is not well controlled
- Inability to tolerate bronchoscopy or contraindication to bronchoscopy, anesthesia, or deep sedation
- Any anatomical limitation of the head and neck, oral cavity or laryngopharynx that may preclude bronchoscopic evaluation or treatment
- Patient with active pulmonary infection, including but not limited to: COVID-19, influenza, etc.
- Any disease or condition that interferes with safe completion of the study, such as severe COPD or severe asthma or pulmonary fibrosis.
- Patients actively being treated with immunosuppressive therapy or with an active immunosuppressed state due to other treatment or underlying disease.
- Pregnancy or planning on pregnant during the first 12 months of enrollment in the study
- Life expectancy <1 year
- Patient is currently enrolled in other investigational studies. Participation in studies for products approved in the US are not considered investigational
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single arm treated by Airiver Pulmonary DCB
subject will be treated by Airiver Pulmonary Drug Coated Balloon (DCB) catheter.
The balloon is coated with a paclitaxel drug (3.5ug/mm2).
|
Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
Time Frame: 30 days
|
MADE is defined as:
|
30 days
|
Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
Time Frame: 6 months
|
The incidence of subjects free from symptom-driven TLR will be assessed via Kaplan-Meier survival analysis.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of, and time to, symptom-driven target lesion reintervention through 12 months.
Time Frame: 12 months
|
assessed via Kaplan-Meier survival analysis.
|
12 months
|
Bronchoscopic target lesion patency (Myer-Cotton airway grading system) change through 12 months.
Time Frame: 12 months
|
Grade 1 - 0-50% obstruction Grade 2 - 51-70% obstruction Grade 3 - 71-99% obstruction Grade 4 - No detectable lumen.
|
12 months
|
Spirometry (FEV1) change through 12 months
Time Frame: 12 months
|
A spirometry will be compared at baseline vs follow-ups.
Lower readings indicate more significant obstruction.
|
12 months
|
mMRC (Modified Medical Research Council) dyspnea scale change through 12 months
Time Frame: 12 months.
|
The grade range is from 0-4.
Higher grades indicate worse respiratory disability.
|
12 months.
|
Quality of life (QOL) change: Patient report outcomes (SF-12) through 12 months
Time Frame: 12 months
|
Converting SF-12 Item Responses to Physical and Mental Standardized Values.
Higher scores indicate better health
|
12 months
|
Clinical pharmacokinetics of paclitaxel by 10 days
Time Frame: 10 days
|
plasma paclitaxel concentration will be assessed per predesignated time points.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kakha Vacharadze, MD, National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2030
Study Registration Dates
First Submitted
May 31, 2023
First Submitted That Met QC Criteria
May 31, 2023
First Posted (Actual)
June 8, 2023
Study Record Updates
Last Update Posted (Actual)
June 8, 2023
Last Update Submitted That Met QC Criteria
May 31, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Oxygen-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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