New treatment option for Multivessel Coronary Artery Disease
Official title Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease
ClinicalTrials.gov ID: NCT01311323
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people must meet ALL of the to be considered for the trial. If ANY of the
You likely can't join if
- are met, the subject is excluded from the trial and cannot be assigned by chance.
- 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...
- 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...
See the full eligibility criteria
- people must meet ALL of the to be considered for the trial. If ANY of the
- are met, the subject is excluded from the trial and cannot be assigned by chance.
- 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...
- 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 treatment cardiologist. Exclusion Criteria:
- Age under 18 years,
- 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,
- Qualification for conservative treatment,
- Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation,
- Need for immediate coronary angioplasty treatment,
- Syntax Score equal or above 33 (\>=33),
- Contraindications to short-term and long-term antiplatelet therapy,
- Acute heart failure in class IV (cardiogenic shock),
- Previous CABG procedure,
- Previous PCI procedure within the last 6 months,
- Ischemic or hemorrhagic stroke within 6 months prior to inclusion,
- End-stage chronic kidney disease on dialysis,
- Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization),
- Non cardiac co-morbidities with life expectancy less than 3 years,
- Participation in other clinical trial that have not reached their primary endpoint.
The study team makes the final eligibility decision.
Where it's taking place
- Chrzanów, Malopolska, Poland
- Bielsko-Biala, Silesian Voivodeship, Poland
- Dąbrowa Górnicza, Silesian Voivodeship, Poland
- Ustroń, Silesian Voivodeship, Poland
- Katowice, Poland
- Kędzierzyn-Koźle, Poland
- Opole, Poland
- Tychy, Poland
- Warsaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chrzanów, Malopolska, Poland; Bielsko-Biala, Silesian Voivodeship, Poland; Dąbrowa Górnicza, Silesian Voivodeship, Poland; Ustroń, Silesian Voivodeship, Poland; Katowice, Poland; Kędzierzyn-Koźle, Poland and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.