Trial Outcomes & Findings for A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis (NCT NCT01253577)

Results Overview

Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

105 participants

Primary outcome timeframe

30-days

Results posted on

2015-06-22

Participant Flow

Patients were recruited in the United States between December 2009 and July 2010 from eleven otolaryngology-head and neck surgery centers by 31 surgeons representing both academic and private practices.

Sinus randomization was performed at the end of successful endoscopic sinus surgery.

Participant milestones

Participant milestones
Measure	Sinus Stent Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
Overall Study STARTED	105
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sinus Stent Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
Overall Study Lost to Follow-up	3

Baseline Characteristics

A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sinus Stent n=105 Participants Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	95 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	46.5 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants

PRIMARY outcome

Timeframe: 30-days

Population: All 105 subjects were present for the primary endpoint exam. However n=96 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.

Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

Outcome measures

Outcome measures
Measure	Drug-Coated Implant Side n=96 Participants Sinus stent coated with steroid	Non-coated Implant Side n=96 Participants Sinus stent without drug coating
Percentage of Sinuses Requiring Post-operative Intervention	33.3 percentage of sinuses Interval 24.0 to 43.7	46.9 percentage of sinuses Interval 36.6 to 57.3

PRIMARY outcome

Timeframe: 90 days

Population: Two patients did not have their ocular exam performed at day 90 (LTFU) but had ocular exams at earlier time points.

clinically significant IOP elevation is a change from baseline of \>10 mm Hg on sinus side with drug-coated implant but not on side with control implant

Outcome measures

Outcome measures
Measure	Drug-Coated Implant Side n=103 Participants Sinus stent coated with steroid	Non-coated Implant Side Sinus stent without drug coating
Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure	0 percentage of patients Interval 0.0 to 3.52	—

SECONDARY outcome

Timeframe: 30 days

Population: All 105 subjects were present for this endpoint exam. However n=85 is the number of subjects where both sinus sides had video-endoscopies able to be graded by the independent panel.

Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons.

Outcome measures

Outcome measures
Measure	Drug-Coated Implant Side n=85 Participants Sinus stent coated with steroid	Non-coated Implant Side n=85 Participants Sinus stent without drug coating
Percentage of Sinuses That Developed Frank Polyposis	18.8 percentage of sinuses Interval 11.2 to 28.8	34.1 percentage of sinuses Interval 24.2 to 45.2

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Patients n=105 participants at risk Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group.
Nervous system disorders Headache	4.8% 5/105 • Number of events 5 • 3 Months
Respiratory, thoracic and mediastinal disorders Epistaxis	2.9% 3/105 • Number of events 3 • 3 Months
Infections and infestations Bronchitis	2.9% 3/105 • Number of events 3 • 3 Months
Infections and infestations Sinusitis	32.4% 34/105 • Number of events 34 • 3 Months

Additional Information

James Stambaugh, Vice President Clinical Affairs

Intersect ENT

Phone: 650-641-2103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60