STRIVE Post-Market Registry Study

Last updated: April 23, 2026
Sponsor: Olympus Corporation of the Americas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Emphysema

Treatment

Spiration Valve System (SVS)

Clinical Study ID

NCT04302272
CPR-05644
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult patients with shortness of breath and hyperinflation associated with severeemphysema and evidence of low collateral ventilation.

  2. Subjects must understand and voluntarily sign an informed consent form.

Exclusion

Exclusion Criteria:

  1. Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFUrequirements.

  2. Subjects who were withdrawn from this study for any reason will not be allowed tore-enroll.

  3. Subjects who have incomplete screening or baseline data.

Study Design

Total Participants: 150
Treatment Group(s): 1
Primary Treatment: Spiration Valve System (SVS)
Phase:
Study Start date:
October 09, 2021
Estimated Completion Date:
October 31, 2029

Study 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.

Connect with a study center

  • Dignity Health St. Joseph's Hospital and Medical Center

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Dignity Health St. Joseph's Hospital and Medical Center

    Phoenix 5308655, Arizona 5551752 85013
    United States

    Site Not Available

  • El Camino, Taft Center for Clinical Research

    Mountain View, California 94040
    United States

    Active - Recruiting

  • El Camino, Taft Center for Clinical Research

    Mountain View 5375480, California 5332921 94040
    United States

    Site Not Available

  • University of Miami

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • Northwestern University, Division of Pulmonary and Critical Care Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Northwestern University, Division of Pulmonary and Critical Care Medicine

    Chicago 4887398, Illinois 4896861 60611
    United States

    Active - Recruiting

  • University of Chicago

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • LSU Health Shreveport

    Shreveport, Louisiana 71130
    United States

    Active - Recruiting

  • LSU Health Shreveport

    Shreveport 4341513, Louisiana 4331987 71130
    United States

    Site Not Available

  • Beth Israel Decaconess

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Beth Israel Decaconess

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Site Not Available

  • Memorial Hospital at Gulfport

    Gulfport, Mississippi 39501
    United States

    Active - Recruiting

  • Memorial Hospital at Gulfport

    Gulfport 4428667, Mississippi 4436296 39501
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • Duke University Medical Center

    Durham 4464368, North Carolina 4482348 27710
    United States

    Site Not Available

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey 5193342, Pennsylvania 6254927 17033
    United States

    Site Not Available

  • Temple University

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • AnMed Health

    Anderson, South Carolina 29621
    United States

    Active - Recruiting

  • AnMed Health

    Anderson 4569298, South Carolina 4597040 29621
    United States

    Site Not Available

  • Baylor Scott & White Research Institute

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Active - Recruiting

  • Baylor Scott & White Research Institute

    Dallas 4684888, Texas 4736286 75204
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont 05401
    United States

    Site Not Available

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