STRIVE Post-Market Registry Study

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04302272
• Other study ID #: 17
• Status: Recruiting
• Start date: October 9, 2021
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: Olympus Corporation of the Americas
• Contact: Lauri DeVore
• Phone: (425) 373-6802
• Email: lauri.devore[@]olympus.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

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

Exclusion Criteria:

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

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.

3. Subjects who have incomplete screening or baseline data.

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• Spiration Valve System (SVS)
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.

Locations

Country	Name	City	State
United States	AnMed Health	Anderson	South Carolina
United States	Beth Israel Decaconess	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	Baylor Scott & White Research Institute	Dallas	Texas
United States	University of Texas Southwestern	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	El Camino, Taft Center for Clinical Research	Mountain View	California
United States	Temple University	Philadelphia	Pennsylvania
United States	Dignity Health St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	LSU Health Shreveport	Shreveport	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Corporation of the Americas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Targeted lobe volume reduction (TLVR)	Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months	6 months
Other	Hyperinflation	It will be measured by the ratio of residual volume to total lung capacity (RV/TLC) using plethysmography from baseline	6 and 12 months
Other	Forced expiratory volume in 1 second (FEV1)	Relative (percentage) change from baseline at 6, 12, 24 and 36 months	6, 12, 24 and 36 months
Other	Modified Medical Research Council (mMRC) change	Modified Medical Research Council (mMRC) change from baseline at 6, 12, 24 and 36 months	6, 12, 24 and 36 months
Other	St. George's Respiratory Questionnaire (SGRQ) change	St. George's Respiratory Questionnaire (SGRQ) change from baseline at 6, 12, 24 and 36 months	6, 12, 24 and 36 months
Other	6 Minute Walk Test (6MWT) change	6-minute walk test (6MWT) change from baseline at 6 and 12 months	6 and 12 months
Other	Body Mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change	Body mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change from baseline at 6 and 12 months	6 and 12 months
Other	Responder Rates based on Minimum Clinically Important Difference (MCID)	Responder rates based on Minimum Clinically Important Difference (MCID) for Effectiveness Observations	3 years
Primary	Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure	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.	12 months
Primary	Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure	An additional analysis will present the rate (per patient-year) of TAEsSI.	36 months
Secondary	45-day pneumothorax rate	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.	45 days
Secondary	Survival rate over 24 months	Survival rate over 24 months compared to the EMPROVE study control cohort	24 months