Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

NCT ID: NCT02831166

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transradial approach

Transradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125).

Group Type: ACTIVE_COMPARATOR

Transradial primary percutaneous coronary intervention

Intervention Type: PROCEDURE

Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow.

Transfemoral approach

Transfemoral approach primary percutaneous coronary intervention using a vascular closure device to obtain hemostasis (n=125).

Group Type: ACTIVE_COMPARATOR

Transfemoral primary percutaneous coronary intervention

Intervention Type: PROCEDURE

Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes.

Interventions

Transradial primary percutaneous coronary intervention

Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow.

Intervention Type: PROCEDURE

Transfemoral primary percutaneous coronary intervention

Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Irmandade Santa Casa Misericórdia Marília

OTHER

Sponsor Role: lead

Responsible Party

Pedro Beraldo de Andrade

MD, phD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pedro B Andrade, phD

Role: PRINCIPAL_INVESTIGATOR

Irmandade SCMM

Locations

Pedro Beraldo de Andrade

Marília, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 24345099 (View on PubMed)

Other Identifiers

50120915.1.0000.5413

Identifier Type: -

Identifier Source: org_study_id