Propel Drug-Eluting Sinus Stent Family Open Cohort

The purpose of this study is to confirm the long-term clinical safety and performance, acceptability of identified risks, and to detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling (in patients with chronic rhinosinusitis (CRS) undergoing sinus surgery). Additionally, this study intends to collect data on use of corticosteroid-eluting implants in the European CRS population. Data collected will be used to ensure continued consistency between clinical data, the information materials supplied by the manufacturer, and the risk management documentation.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Other: NA-Observational Registry

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Germany
  • Cologne, Germany
    • Saint Elisabeth Krankenhaus Köln-Hohenlind
  • Freiburg im Breisgau, Germany
    • Universitätsklinikum Freiburg Klinik für Hals, Nasen und Ohrenheilkunde
  • Hagen, Germany
    • Katholisches Krankenhaus Hagen
  • Karlsruhe, Germany
    • Städtisches Klinikum Karlsruhe GmbH
  • Lübeck, Germany
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
  • München, Germany
    • HNO Praxis & Rhinologie Zentrum München
  • Münster, Germany
    • Universitätsklinikum Münster Klinik für Hals, Nasen und Ohrenheilkunde
  • Wiesbaden, Germany
    • Helios Dr Horst Schmidt Kliniken
• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust - Charing Cross Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

European CRS population implanted with Propel implants

Description

Inclusion Criteria:

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
• Patient has or is intended to receive or be treated with an eligible Medtronic product
• Patient is consented within the enrollment window of the therapy received, as applicable

Exclusion Criteria:

• Patient who is, or is expected to be, inaccessible for follow-up
• Participation is excluded by local law
• Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Propel; Patients implanted with Propel model implants	Other: NA-Observational Registry; NA Observational Registry
Propel Mini; Patients implanted with Propel Mini model implants	Other: NA-Observational Registry; NA Observational Registry
Propel Contour; Patients implanted with Propel Contour model implants	Other: NA-Observational Registry; NA Observational Registry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term safety and efficacy of corticosteroid-eluting implants in patients with CRS undergoing Functional Endoscopic Sinus Surgery (FESS)	The primary efficacy endpoint is Sino-Nasal Outcome Test 22 item (SNOT-22) total score change from baseline to Month 6. The SNOT-22 assesses 22 symptoms associated with Chronic Rhinosinusitis (CRS) with a value from 0 (no problem) to 5 (problem as bad as it can be). The total score is assessed by summing the score for each of the 22 items. Total SNOT-22 scores of 20 and greater in patients with CRS meet criteria defined by European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020) as indicated for Functional Endoscopic Sinus Surgery (FESS). Baseline SNOT-22 total scores are expected to be higher at baseline prior to FESS. A decrease in SNOT-22 score at 6 months would indicate improvement in the patient's CRS symptoms.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic evaluation	Endoscopic evaluation scoring from baseline to month 3, 6, and12. Endoscopic evaluation is the physician's assessment via endoscopy of the adhesion/scarring, polyps, patency, polypoid oedema, and middle turbinate lateralization of the sinuses from 0 (none) to 3-4 (most severe) prior to FESS, and following FESS and Propel stent placement at 3, 6 and 12 months. Lower scores at follow-up would indicate improvement in the patient's CRS and healing compared to baseline.	12 months

Collaborators and Investigators

• Sponsor: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): February 19, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease
• Other Study ID Numbers: PSR Ear, Nose and Throat

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes