STRIVE Post-Market Registry Study for Emphysema

This study is looking at the long-term safety and effectiveness of the Spiration Valve System (SVS) for adults with severe emphysema. Emphysema is a lung condition that causes shortness of breath. The Spiration Valve System uses one-way valves placed in the lungs to help improve breathing. To join, you must be an adult with severe emphysema and have low collateral ventilation (a specific lung characteristic). The study will track how often certain chest-related side effects occur over 12 and 36 months after the valves are implanted. This study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning participants will be monitored without being assigned to different treatment groups. It plans to include 150 participants.
What's involved
You will be monitored for outcome data from when you start the study through 3 years after your first implant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 36 months (3 years) after the first implantation procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04302272

STRIVE Post-Market Registry Study

Recruiting
Not specifiedAges 18+Observational
Olympus Corporation of the Americas
~150 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Spiration Valve System (SVS)

At a glance

Recruiting sites
15 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
Measured over 12 months
+1 more outcome measured
Emphysema
16 sites across 12 states
Texas3
Illinois2
Pennsylvania2
Arizona1
California1
Florida1
Louisiana1
Maryland1
  • Gerard Criner, MD · PRINCIPAL_INVESTIGATOR · Temple University

Opens a ready-to-send draft in your own email app — review before sending.

  • Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure12 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 procedure36 months

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