Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention (NCT02831166) | Clinical Trial Compass
CompletedPhase 4
Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
Brazil250 participantsStarted 2016-01
Plain-language summary
Primary percutaneous coronary intervention represents the gold standard for the treatment of ST-segment-elevation acute myocardial infarction. However, periprocedural bleedings are associated with an increased risk of mortality, re-infarction, and stroke. Although the prognostic value of access site related bleeding complications is still debated, transradial approach is associated with better short-term outcomes and reduced hospital stay as compared to transfemoral approach. The investigators aimed to compare transradial approach with transfemoral approach with systematic achievement of hemostasis by the implantation of a vascular closure device in a national multicentre randomized clinical trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ST-segment elevation acute myocardial infarction patients during the first 12 hours of sympton onset;
* Intention to perform primary percutaneous coronary intervention;
* Signed informed consent;
* Patient eligible for transradial and transfemoral primary percutaneous coronary intervention, being pre-requisites: (a) familiarity of the operator with the radial and femoral techniques using vascular closure devices, (b) agreement of the operator to use the access route determined by the randomization process.
Exclusion Criteria:
* Less than 18 years of age;
* Pregnancy;
* Chronic use of vitamin K antagonists or direct thrombin inhibitors, or oral Xa-factor antagonists;
* Hypersensitivity to antiplatelet and/or anticoagulant drugs;
* Active bleeding or high bleeding risk (severe liver failure, active peptic ulcer, creatinine clearance \< 30 mL/min, platelets count \< 100.000 mm3);
* Uncontrolled systemic hypertension;
* Cardiogenic shock;
* Previous myocardial revascularization surgery with ≥ 1 internal mammary or radial artery graft;
* Documented chronic peripheral arterial disease preventing the use of the femoral technique;
* Severe concomitant disease with life expectancy below 12 months;
* Participation in drug or devices investigative clinical trials in the last 30 days;
* Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.