STRIVE Post-Market Registry Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• Incidence of pre-specified thoracic adverse events of special interest (TAEsSI) through 12 months following the first implantation procedure [Срок оценки: 12 months]
• Rate (per patient-year) of pre-specified thoracic adverse events of special interest (TAEsSI) through 36 months following the first implantation procedure [Срок оценки: 36 months]

Вторичные конечные точки (2)

• 45-day pneumothorax rate [Срок оценки: 45 days]
• Survival rate over 24 months [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Adult patients with shortness of breath and hyperinflation associated with severe emphysema and evidence of low collateral ventilation.
• Subjects must understand and voluntarily sign an informed consent form.

Критерии исключения

• Subjects who are not appropriate for SVS therapy based upon the US FDA-approved IFU requirements.
• Subjects who were withdrawn from this study for any reason will not be allowed to re-enroll.
• Subjects who have incomplete screening or baseline data.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 16 центров

• Dignity Health St. Joseph's Hospital and Medical Center — Phoenix
• El Camino, Taft Center for Clinical Research — Mountain View
• University of Miami — Coral Gables
• Northwestern University, Division of Pulmonary and Critical Care Medicine — Chicago
• University of Chicago — Chicago
• LSU Health Shreveport — Shreveport
• University of Maryland — Baltimore
• Beth Israel Decaconess — Boston
• … и ещё 8 центров

Идентификаторы

NCT: NCT04302272 · CPR-05644

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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