STRIVE Post-Market Registry Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emphysema
• Intervention / Treatment: Device: Spiration Valve System (SVS)

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Lauri DeVore; Phone Number: (425) 373-6802; Email: lauri.devore@olympus.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Not yet recruiting
      • Dignity Health St. Joseph's Hospital and Medical Center
      • Contact: Qabas Elkurwi; Phone Number: 602-406-3109; Email: qabas.elkurwi@commonspirit.org
      • Principal Investigator: Abid Khokar, MD
  • California
    • Mountain View, California, United States, 94040
      • Recruiting
      • El Camino, Taft Center for Clinical Research
      • Contact: Winston Ku; Phone Number: 650-962-4623; Email: winston_ku@elcaminohealth.org
      • Principal Investigator: Ganesh Krishna, MD
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • University Of Chicago
      • Principal Investigator: Kyle Hogarth, MD
      • Contact: Karina Mak; Phone Number: 773-702-4012; Email: kmak@bsd.uchicago.edu
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • Not yet recruiting
      • LSU Health Shreveport
      • Principal Investigator: Robert Holladay, MD
      • Contact: Misty Prince; Phone Number: 318-813-1456; Email: misty.prince@lsuhs.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Decaconess
      • Principal Investigator: Adnan Majid, MD
      • Contact: Makayla Durant; Phone Number: 617-632-8095; Email: mdurant1@bidmc.harvard.edu
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
      • Contact: Jessica Shier; Phone Number: 919-668-3812; Email: jessica.shier@duke.edu
      • Principal Investigator: Coral Giovacchini, MD
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S. Hershey Medical Center
      • Principal Investigator: Michael Reed, MD
      • Contact: Karen Bright; Phone Number: 285155 717-531-0003; Email: kbright@pennstatehealth.psu.edu
      • Contact: Damaris Romberger; Phone Number: 286789 7175310003; Email: dromberger1@pennstatehealth.psu.edu
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Principal Investigator: Gerard Criner, MD
      • Contact: Helga Criner; Phone Number: 215-707-1559; Email: Lii-Yoong.Criner@tuhs.temple.edu
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Recruiting
      • AnMed Health
      • Principal Investigator: Abhijit Raval, MD
      • Contact: Melissa Frankum; Phone Number: 864-512-8734; Email: Melissa.Frankum@anmed.org
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern
      • Principal Investigator: Muhanned Abu-Hijleh, MD
      • Contact: Ruby Thapa; Phone Number: 214-645-6493; Email: ruby.thapa@utsouthwestern.edu
    • Dallas, Texas, United States, 75204
      • Recruiting
      • Baylor Scott & White Research Institute
      • Principal Investigator: Gary Schwartz, MD
      • Contact: Sharon Brown; Phone Number: 214-820-0338; Email: SHARON.BROWN1@BSWHEALTH.ORG
      • Sub-Investigator: Katherine Vandervest, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Survival rate over 24 months	Survival rate over 24 months compared to the EMPROVE study control cohort	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Targeted lobe volume reduction (TLVR)	Target lobe volume reduction (TLVR) determined from quantitative High-Resolution Computed Tomography (HRCT) at 6 months	6 months
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
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
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
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
6 Minute Walk Test (6MWT) change	6-minute walk test (6MWT) change from baseline at 6 and 12 months	6 and 12 months
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
Responder Rates based on Minimum Clinically Important Difference (MCID)	Responder rates based on Minimum Clinically Important Difference (MCID) for Effectiveness Observations	3 years

Collaborators and Investigators

• Sponsor: Olympus Corporation of the Americas

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2021
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Emphysema; Chronic obstructive pulmonary disease (COPD); Spiration valve system
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes