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LIPSIASTRATEGYNCT03497637

Comparison of Vessel-FFR Versus FFR in Intermediate Coronary Stenoses

StatusActive, Not Recruiting
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 12 versions: 12 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 9 more changesShow less
    • Primary completion date changed from estimate of May 1, 2026 to Feb 12, 2026
    • Study completion pushed from Nov 1, 2026 to Nov 5, 2029
    • Interventions modified
    • Start date: Oct 23, 2020 to Jun 20, 2020
    • Eligibility criteria expanded, about 11 words
    • Study description shortened, about 23 words
    • Site details revised at 8 of 8 sites
    • Collaborators: 1 to 2
    • Publications: details revised at 1 of 1 entry
  2. Enrollment target: 1926 to 1054v11
  3. Study sites: 7 to 8v10
  4. Primary completion date: Nov 1, 2021 to May 1, 2026
    • Study sites: 1 to 7
    v9
  5. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Primary completion date: Sep 1, 2021 to Nov 1, 2021
    • Study completion date: Sep 1, 2026 to Nov 1, 2026
    • Start date changed from estimate of Sep 1, 2020 to Oct 23, 2020
    • Site details revised
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Jul 1, 2020 to Sep 1, 2020v7 Show 5 more changesShow less
    • Primary completion date: Jul 1, 2022 to Sep 1, 2021
    • Study completion date: Jul 1, 2025 to Sep 1, 2026
    • Study description shortened, about 128 words
    • Study title revised
    • Eligibility criteria expanded, about 5 words
  2. Primary completion date: Jan 1, 2022 to Jul 1, 2022
    • Start date: Jan 1, 2020 to Jul 1, 2020
    • Study completion date: Jan 1, 2025 to Jul 1, 2025
    v6
  3. Primary completion date: Jul 1, 2021 to Jan 1, 2022
    • Start date: Jul 1, 2019 to Jan 1, 2020
    • Study completion date: Jul 1, 2024 to Jan 1, 2025
    v5
  4. Primary completion date: Jan 1, 2021 to Jul 1, 2021
    • Start date: Jan 1, 2019 to Jul 1, 2019
    • Study completion date: Jan 1, 2024 to Jul 1, 2024
    v4
  5. Start date: Oct 1, 2018 to Jan 1, 2019
    • Primary completion date: Oct 1, 2020 to Jan 1, 2021
    • Study completion date: Oct 1, 2023 to Jan 1, 2024
    v3
  6. Start date: Jun 1, 2018 to Oct 1, 2018
    • Primary completion date: Jun 1, 2020 to Oct 1, 2020
    • Study completion date: Jun 1, 2023 to Oct 1, 2023
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Major Adverse Cardiac Event (MACE) rate
Timeframe: 1 year

Secondary (6)

MACE during long-term follow-up
Each component of the primary endpoint assessed by structured telephone interview and verification by hospital reports
Repeat revascularization (PCI or CABG) assessed by structured telephone interview and verification by hospital reports in case of event
All-cause mortality
Cross-over rate from the one strategy to the other
Show 1 moreShow less
Number of analyzable lesions in both treatment arms

Arms and interventions

vFFR-guided PCIActive comparator

Patients undergo percutaneous coronary intervention (PCI) guided by vessel fractional flow reserve (vFFR). vFFR is computed using 3D angiographic reconstruction software to assess the hemodynamic significance of coronary stenoses without the use of an invasive pressure wire or hyperemic agents.

FFR-guided PCIActive comparator

Patients undergo percutaneous coronary intervention (PCI) guided by standard invasive fractional flow reserve (FFR). FFR is measured using an intracoronary pressure wire under maximal hyperemia to assess the hemodynamic significance of coronary stenoses.

Diagnostic tests: Measurement of FFR, Measurement of vFFR

Sites

8 sites in 1 country