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Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Study acronym: MILESTONE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 7 to 9v6
  2. Study sites: 5 to 7
    • Eligibility criteria expanded, about 22 words
    v5
  3. Start date changed from estimate of Aug 2025 to Aug 25, 2025
    • Site details revised at 4 of 5 sites
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Primary completion date: Jan 2025 to Dec 2028
    • Start date: Jan 2021 to Aug 2025
    • Study sites: 7 to 5
    • Study completion date: Jun 2025 to Nov 2030
    • Eligibility criteria expanded, about 67 words
    • Study description revised
    • Collaborators: 4 to 1
    • Publications reordered
  5. Primary completion date: Jan 2015 to Jan 2025v2 Show 9 more changesShow less
    • Start date: Jun 2011 to Jan 2021
    • Primary endpoint revised
    • Study sites: 5 to 7
    • Study completion date: Jan 2016 to Jun 2025
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 657 words
    • Collaborators expanded, about 28 words
    • Study title shortened, about 2 words
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and/or with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC/AHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS). Similarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction. In the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE \<5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.
Trial Details
NCT Number NCT01311323
Lead Sponsor American Heart of Poland
Collaborators: Andrzej Frycz Modrzewski Krakow University
Conditions
(from sponsor)		 Multivessel Coronary Artery Disease, Acute Coronary Syndrome
Related terms Acute Coronary Syndrome
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov