RecruitingNot Applicable

STRIVE Post-Market Registry Study

United States150 participantsStarted 2021-10-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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

What they're measuring

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

Timeframe: 12 months

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

Timeframe: 36 months

Trial details

NCT IDNCT04302272

SponsorOlympus Corporation of the Americas

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12

Contact for this trial

Courtney Inge

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

View on ClinicalTrials.gov More Emphysema trials