STRIVE Post-Market Registry Study

Olympus Corporation of the Americas150 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

Emphysema

Interventions

Spiration Valve System (SVS)DEVICE

Spiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll. 3.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.

Locations (13)

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

RECRUITING

El Camino, Taft Center for Clinical Research

Mountain View, California, United States

Outcomes

Primary Outcomes

Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure

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.

Time frame: 12 months

Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure

An additional analysis will present the rate (per patient-year) of TAEsSI.

Time frame: 36 months

Secondary Outcomes

45-day pneumothorax rate

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.

Time frame: 45 days

Survival rate over 24 months

Survival rate over 24 months compared to the EMPROVE study control cohort

Time frame: 24 months

Central Contacts

Courtney Inge

CONTACT

703-201-0680 courtney.inge@olympus.com

Adorn Nelson

CONTACT

(281) 221-6665 adorn.nelson@olympus.com

Data from ClinicalTrials.gov

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