Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04302272

STRIVE Post-Market Registry Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Emphysema Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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  • Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 36 months

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

Secondary outcomes

  1. 45-day pneumothorax rate

    Time frame: 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.

  2. Survival rate over 24 months

    Time frame: 24 months

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

Other outcomes

  1. Targeted lobe volume reduction (TLVR)

    Time frame: 6 months

    Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months

  2. Hyperinflation

    Time frame: 6 and 12 months

    It will be measured by the ratio of residual volume to total lung capacity (RV/TLC) using plethysmography from baseline

  3. Forced expiratory volume in 1 second (FEV1)

    Time frame: 6, 12, 24 and 36 months

    Relative (percentage) change from baseline at 6, 12, 24 and 36 months

  4. Modified Medical Research Council (mMRC) change

    Time frame: 6, 12, 24 and 36 months

    Modified Medical Research Council (mMRC) change from baseline at 6, 12, 24 and 36 months

  5. St. George's Respiratory Questionnaire (SGRQ) change

    Time frame: 6, 12, 24 and 36 months

    St. George's Respiratory Questionnaire (SGRQ) change from baseline at 6, 12, 24 and 36 months

  6. 6 Minute Walk Test (6MWT) change

    Time frame: 6 and 12 months

    6-minute walk test (6MWT) change from baseline at 6 and 12 months

  7. Body Mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change

    Time frame: 6 and 12 months

    Body mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change from baseline at 6 and 12 months

  8. Responder Rates based on Minimum Clinically Important Difference (MCID)

    Time frame: 3 years

    Responder rates based on Minimum Clinically Important Difference (MCID) for Effectiveness Observations

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Inge

CONTACT

[email protected]

703-201-0680

Sharon Rabine

CONTACT

[email protected]

479-644-7840

Sponsors and collaborators

Lead sponsor

Olympus Corporation of the Americas

Industry

Registry information

Official study title

The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Mar 10, 2020
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.