NCT01311323Recruiting
Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
Multivessel and Left Main Coronary Artery Stenting in Comparison With Surgical Revascularization in Patients With Non ST Elevation Acute Coronary Syndrome. Prospective, Clinical Randomized Trial (The MILESTONE Trial)
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 8 Mar 2011
- Start date
- Aug 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- American Heart of Poland
- Diseases
- Coronary artery disease
- NCT number
- NCT01311323
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From Aug 2025 to the primary completion date, Dec 2028
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation,
- Contraindications to short-term and long-term antiplatelet therapy,
- Previous CABG procedure,
- Previous PCI procedure within the last 6 months,
- Ischemic or hemorrhagic stroke within 6 months prior to inclusion,
- Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization),
Other illness
- ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB),
- Stable coronary syndrome,
- Single- or two-vessel coronary disease without involvement of the proximal LAD, defined as narrowing above 50%DS,
- Acute heart failure in class IV (cardiogenic shock),
- End-stage chronic kidney disease on dialysis,
- Non cardiac co-morbidities with life expectancy less than 3 years,
Age
- Age under 18 years,
Other
- Qualification for conservative treatment,
- Need for immediate coronary angioplasty treatment,
- Syntax Score equal or above 33 (\>=33),
- Participation in other clinical trial that have not reached their primary endpoint.
Who the study is looking for
- Subjects must meet ALL of the inclusion criteria to be considered for the trial. If ANY of the exclusion criteria are met, the subject is excluded from the trial and cannot be randomized.
- Age over 18 years,
- Written patient consent,
- Acute Coronary Syndrome without ST-segment elevation of high, intermediate and low risk, including NSTEMI and unstable angina requiring urgent (within 72 hours) invasive strategy,
- Qualification for invasive treatment,
- Multivessel coronary disease, defined as angiographic narrowing \>50%DS on investigator's visual assessment in at least two major coronary artery territories (RCA, LAD, LCX), including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \< 33. Intermediate lesions (40-70%) will need to be assessed with either FFR, iFR, or VFFR). Patient may have left main coronary artery disease, defined as narrowing \>50%DS (but this is not obligatory). For borderline changes, IVUS (MLA \<6 mm2 or iFR=\<0,90 or FFR=\<0,80, with an anatomic Syntax Score \<33 will be decisive,
- Feasibility of complete revascularization on both the CABG and PCI sides,
- Consent within the Heart Team for both CABG by the cardiothoracic surgeon and PCI by the interventional cardiologist.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Polish-American Heart Clinics Center for Cardiology and Cardiac Surgery Outpatient Specialist Care in Bielsko-Biała Coordinator of this site? Confirm its status | Bielsko-Biala | Poland | Recruiting |
| Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów Coordinator of this site? Confirm its status | Chrzanów | Poland | Recruiting |
| Polish-American Heart Clinics III Department of Invasive Cardiology, Angiology and Electrocardiology Coordinator of this site? Confirm its status | Dąbrowa Górnicza | Poland | Recruiting |
| Upper Silesian Medical Center in Katowice Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Polish-American Heart Clinics Cardiovascular Center in Kędzierzyn-Koźle Coordinator of this site? Confirm its status | Kędzierzyn-Koźle | Poland | Recruiting |
| University Clinical Hospital in Opole Coordinator of this site? Confirm its status | Opole | Poland | Recruiting |
| Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy Coordinator of this site? Confirm its status | Tychy | Poland | Recruiting |
| Polish-American Heart Clinics, 1st Department of Cardiology and Angiology in Ustroń Coordinator of this site? Confirm its status | Ustroń | Poland | Recruiting |
| National Medical Institute of the Ministry of the Interior and Administration Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.