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REDUCER-I: An Observational Study of the Neovasc Reducer™ System

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 5 versions Re-verified since Jul 9, 2024, no change to tracked fieldsv15-v19
  2. Primary completion date changed from estimate of Dec 2023 to Nov 2023
    • Interventions: Neovasc Reducer System (Device) to Reducer System (Device)
    v14
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 28 to 25
    v13
  4. Primary completion date: Dec 2022 to Dec 2023
    • Study sites: 26 to 28
    • Study completion date: Dec 2027 to Dec 2028
    v12
  5. Study sites: 25 to 26v11
Show 9 earlier versionsHide 9 earlier versions
  1. Eligibility criteria expanded, about 84 words
    • Study sites revised (25)
    v10
  2. Study sites: 23 to 25
    • Publications: 6 to 7
    v9
  3. Study sites revised (23)v8
  4. Primary completion date: Jul 2019 to Dec 2022
    • Study sites: 21 to 23
    • Study completion date: Aug 2024 to Dec 2027
    v7
  5. Study sites: 20 to 21v6
  6. Site contacts updated at 3 of 20 sitesv5
  7. Study sites: 17 to 20v4
  8. Primary completion date: Sep 2017 to Jul 2019
    • Study sites: 12 to 17
    • Study completion date: Apr 2022 to Aug 2024
    • Publications: 3 to 6
    v3
  9. Study sites: 1 to 12v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to collect long term data of the Reducer System in subjects with refractory angina pectoris.
Trial Details
NCT Number NCT02710435
Lead Sponsor Shockwave Medical, Inc.
Conditions
(from sponsor)		 Angina Pectoris, Angina Pectoris, Stable, Chronic Stable Angina
Related terms Angina Pectoris, Angina, Stable
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov