Clinical trial NCT04302272: STRIVE Post-Market Registry Study
Official title: The Spiration® Valve System (SVS) Post-Market Registry Study for Severe Emphysema
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emphysema
Keywords: Emphysema
Chronic obstructive pulmonary disease (COPD)
Spiration valve system
Lead sponsor: Olympus Corporation of the Americas
Sponsor class: INDUSTRY
First posted: 2020-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation.

Brief 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.

Detailed 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.

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 Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.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

Primary outcomes:
measure: Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure
timeFrame: 12 months
measure: 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
Secondary outcomes:
measure: 45-day pneumothorax rate
timeFrame: 45 days
measure: Survival rate over 24 months
timeFrame: 24 months
Other outcomes:
measure: Targeted lobe volume reduction (TLVR)
timeFrame: 6 months
measure: Hyperinflation
timeFrame: 6 and 12 months
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: 6, 12, 24 and 36 months
measure: Modified Medical Research Council (mMRC) change
timeFrame: 6, 12, 24 and 36 months
measure: St. George's Respiratory Questionnaire (SGRQ) change
timeFrame: 6, 12, 24 and 36 months
measure: 6 Minute Walk Test (6MWT) change
timeFrame: 6 and 12 months
measure: Body Mass, Airflow Obstruction, Dyspnea and Exercise Capacity (BODE) Index change
timeFrame: 6 and 12 months
measure: Responder Rates based on Minimum Clinically Important Difference (MCID)
timeFrame: 3 years
Locations:
city: Phoenix
country: United States
facility: Dignity Health St. Joseph's Hospital and Medical Center
state: Arizona
city: Mountain View
country: United States
facility: El Camino, Taft Center for Clinical Research
state: California
city: Chicago
country: United States
facility: Northwestern University, Division of Pulmonary and Critical Care Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Shreveport
country: United States
facility: LSU Health Shreveport
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Decaconess
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
Study officials:
affiliation: Temple University
name: Gerard Criner, MD
role: PRINCIPAL_INVESTIGATOR
References: