STRIVE Post-Market Registry Study

Recruiting

• Conditions: Emphysema

• Registration Number: NCT04302272
• Lead Sponsor: Olympus Corporation of the Americas

Brief Summary

This is a single-arm, prospective, multi-center, Registry study to evaluate the long-term safety and effectiveness of the Spiration Valve System (SVS) for the treatment of severe emphysema in a post-market setting.

Detailed Description

This post-market study is a single-arm, prospective, multi-center Registry. It is designed to assess 36-month safety and effectiveness of this FDA approved product in a post-approval setting, and to support the continued assessment of Spiration Valve System therapy for the treatment of severe emphysema in the United States.

Subjects who are eligible and consent to be in this study, will be monitored for outcome data from baseline through 3 years post-first implant.

Study Timeline

• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Study Start: 2021-10-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
2. Subjects must understand and voluntarily sign an informed consent form.

Exclusion Criteria

1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
2. Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
3. Subjects who have incomplete screening or baseline data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure	12 months	The primary safety endpoint will be the incidence of device-related and procedure-related pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure.
Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure	36 months	An additional analysis will present the rate (per patient-year) of TAEsSI.

Secondary Outcome Measures

Name	Time	Method
45-day pneumothorax rate	45 days	45-day pneumothorax rate, defined as pneumothorax requiring surgical intervention, or prolonged air leak \> 7 days defined as the time from chest tube insertion to the time the air leak is not present.
Survival rate over 24 months	24 months	Survival rate over 24 months compared to the EMPROVE study control cohort

Trial Locations

Locations (12)

Northwestern University, Division of Pulmonary and Critical Care Medicine; 🇺🇸 Chicago, Illinois, United States

Dignity Health St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

El Camino, Taft Center for Clinical Research; 🇺🇸 Mountain View, California, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

LSU Health Shreveport; 🇺🇸 Shreveport, Louisiana, United States

Beth Israel Decaconess; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

AnMed Health; 🇺🇸 Anderson, South Carolina, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States