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

Primary Purpose

Myocardial Infarction, Complications; Device, Vascular, Injury of Radial Artery

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Transradial primary percutaneous coronary intervention

Transfemoral primary percutaneous coronary intervention

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Vascular closure devices, Transradial approach, Transfemoral approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pedro Beraldo de Andrade

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Transradial approach

Transfemoral approach

Arm Description

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

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

Outcomes

Primary Outcome Measures

Major vascular access site complications

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

Device success

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.

Full Information

NCT ID

NCT02831166

First Posted

July 2, 2016

Last Updated

February 10, 2020

Sponsor

Irmandade Santa Casa Misericórdia Marília

1. Study Identification

Unique Protocol Identification Number

NCT02831166

Brief Title

Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

Acronym

ARISE-2

Official Title

A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Irmandade Santa Casa Misericórdia Marília

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Vascular closure devices, Transradial approach, Transfemoral approach

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transradial approach

Arm Type

Active Comparator

Arm Description

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

Arm Title

Transfemoral approach

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Transradial primary percutaneous coronary intervention

Intervention Description

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

Intervention Name(s)

Transfemoral primary percutaneous coronary intervention

Intervention Description

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 Measure Information:

Title

Major vascular access site complications

Description

Time Frame

48 hours post-procedure

Secondary Outcome Measure Information:

Title

Device success

Description

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.

Time Frame

48 hours post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pedro B Andrade, phD

Organizational Affiliation

Irmandade SCMM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pedro Beraldo de Andrade

City

Marília

State/Province

São Paulo

ZIP/Postal Code

17515900

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24345099

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.

Results Reference

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Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention

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