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.
STRIVE Post-Market Registry Study
At a glance
Conditions
Where it's being run
16 sites across 12 statesStudy leadership
- Gerard Criner, MD · PRINCIPAL_INVESTIGATOR · Temple University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.