Clinical trial NCT02831166: Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
Official title: A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Myocardial Infarction
Complications; Device, Vascular
Injury of Radial Artery
Injury; Blood Vessel, Femoral, Artery
Keywords: Vascular closure devices
Transradial approach
Transfemoral approach
Lead sponsor: Irmandade Santa Casa Misericórdia Marília
Sponsor class: OTHER
First posted: 2016-07-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Major vascular access site complications
timeFrame: 48 hours post-procedure
Secondary outcomes:
measure: Device success
timeFrame: 48 hours post-procedure
Other outcomes:
Locations:
city: Marília
country: Brazil
facility: Pedro Beraldo de Andrade
state: São Paulo
Study officials:
affiliation: Irmandade SCMM
name: Pedro B Andrade, phD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Andrade PB, E Mattos LA, Tebet MA, Rinaldi FS, Esteves VC, Nogueira EF, Franca JI, de Andrade MV, Barbosa RA, Labrunie A, Abizaid AA, Sousa AG. Design and rationale of the AngioSeal versus the Radial approach In acute coronary SyndromE (ARISE) trial: a randomized comparison of a vascular closure device versus the radial approach to prevent vascular access site complications in non-ST-segment elevation acute coronary syndrome patients. Trials. 2013 Dec 18;14:435. doi: 10.1186/1745-6215-14-435.