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Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention (ARISE-2)

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ClinicalTrials.gov Identifier: NCT02831166
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Pedro Beraldo de Andrade, 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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Complications; Device, Vascular Injury of Radial Artery Injury; Blood Vessel, Femoral, Artery Procedure: Transradial primary percutaneous coronary intervention Procedure: Transfemoral primary percutaneous coronary intervention Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
Actual Study Start Date : January 2016
Actual Primary Completion Date : October 2019
Actual Study Completion Date : November 2019

Arm Intervention/treatment
Active Comparator: Transradial approach
Transradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125).
Procedure: 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.

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




Primary Outcome Measures :
  1. Major vascular access site complications [ Time Frame: 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 :
  1. Device success [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831166


Locations
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Brazil
Pedro Beraldo de Andrade
Marília, São Paulo, Brazil, 17515900
Sponsors and Collaborators
Irmandade Santa Casa Misericórdia Marília
Investigators
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Principal Investigator: Pedro B Andrade, phD Irmandade SCMM

Publications:
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Responsible Party: Pedro Beraldo de Andrade, MD, phD, Irmandade Santa Casa Misericórdia Marília
ClinicalTrials.gov Identifier: NCT02831166    
Other Study ID Numbers: 50120915.1.0000.5413
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Pedro Beraldo de Andrade, Irmandade Santa Casa Misericórdia Marília:
Vascular closure devices
Transradial approach
Transfemoral approach
Additional relevant MeSH terms:
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Myocardial Infarction
Vascular System Injuries
Infarction
Wounds and Injuries
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Hemostatics
Coagulants