Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis (RESTORE2)

A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects

This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
• Intervention / Treatment: Procedure: ESS; Combination product: Airiver ESSpand DCB

Detailed Description

Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Operation Director; Phone Number: 6123108755; Email: schachererr@airiver.com
• Study Contact Backup: Name: Chief Operation Officer; Email: vajgrtp@airiver.com

Study Locations

• United States
  • Minnesota
    • Brooklyn Park, Minnesota, United States, 55428
      • Airiver Medical
      • Contact: Clinical Operation Director; Phone Number: 6123108755; Email: schachererr@airiver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, aged ≥18 years
2. Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
3. Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
4. Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
5. Baseline SNOT-22 score ≥ 30
6. Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
7. Willing and able to provide written informed consent
8. Willing and able to comply with all protocol follow up visits and assessments

Exclusion Criteria:

1. Nasal cavity tumor (malignant or benign)
2. Antrochoanal polyps
3. Previous complete middle turbinate resection
4. Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
5. History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
6. Concurrent condition requiring active chemotherapy and/or immunotherapy management
7. Subjects whose symptoms are too severe to undergo ESS (e.g., temperature >102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
8. History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
9. History of primary ciliary dyskinesia
10. Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
11. Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
12. Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit.
13. Allergy or hypersensitivity to paclitaxel or structurally related compounds.
14. Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months.
15. Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment.
16. Subject who plans to undergo posterior nasal nerve ablation in the next 24 months.
17. Subject has a history of inability to tolerate nasal endoscopy
18. Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
19. Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
20. Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment.
21. Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery.
22. Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
23. Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents.
24. Subject whose study index procedure is aborted for any reason
25. Life expectancy <2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: • Treatment with the Airiver ESSpand DCB and ESS; Subjects will have ESSpand DCB dilation of the ESS treated sinuses
Active Comparator: Treatment with ESS; Subjects will have ESS treatment at target sinuses	Procedure: ESS; traditional ESS treatment of diseased sinuses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety	Incidence of major adverse events (MAE) through 30 days post-index treatment.	30 days post- index procedure
Primary efficacy endpoint	Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure.	6 months post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothesis tested clinical responder rate at 12 months	a responder is defined as a subject who has not undergone revision ESS, balloon sinus dilation, or any other procedural intervention, or received oral/systemic steroid or biologic therapy for CRS in the follow-up period, and with SNOT-22 score change from baseline (CFBL) by ≥8.9 points	12 months
Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer	Grading 0 to 3, the higher grade indicates significant scarring and adhesion	6 months

Collaborators and Investigators

• Sponsor: Airiver Medical, Inc.
• Investigators: Principal Investigator: Rodney Schlosser, MD, Medical University of South Carolina; Principal Investigator: Noem Cohen, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 28, 2028
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: PR3056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes