Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

Phase 4

Completed

• Conditions: Myocardial Infarction; Complications; Device, Vascular; Injury; Blood Vessel, Femoral, Artery; Injury of Radial Artery

• Registration Number: NCT02831166
• Lead Sponsor: Irmandade Santa Casa Misericórdia Marília

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-07-02
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-13
• Primary Completion: 2019-10
• Study Completion: 2019-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Major vascular access site complications	48 hours post-procedure	Major vascular complications related to arterial access site will be evaluated during hospitalization by physical examination and duplex ultrassonography and include major bleeding, retroperitoneal hemorrhage, compartment syndrome, pseudoaneurysm, arteriovenous fistula, limb ischemia or need for vascular surgery repair.

Secondary Outcome Measures

Name	Time	Method
Device success	48 hours post-procedure	The success of the device is defined as the attainment of adequate hemostasis at the end of the procedure, without the need to apply other compression methods.

Trial Locations

Locations (1)

Pedro Beraldo de Andrade; 🇧🇷 Marília, São Paulo, Brazil