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AngioSeal Versus Radial Approach in Acute Coronary Syndrome (ARISE)

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Percutaneous coronary intervention

About this trial

This is an interventional supportive care trial for Acute Coronary Syndrome focused on measuring Transradial Approach, Transfemoral Approach, Vascular Closure Device

Eligibility Criteria

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

Inclusion Criteria:

Non-ST-segment elevation ACS patients [ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation of worsening of chest pain characteristic of ischemia, at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST segment depression of at least 1 mm, or transient ST segment elevation, or ST segment elevation ≤ 1 mm, or T wave inversion > 2 mm in at least 2 contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis markers changes, however with previous documentation of coronary atherosclerotic disease (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant CAD confirmed by coronary angiography, or positive functional test for myocardial ischemia];
Intention to submit patient to early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission;
Signed informed consent;
Patient eligible for transradial and transfemoral coronary angiography and PCI, being pre-requisites: (a) palpable radial artery with normal Allen test or/and oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) 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;
Indication of elective percutaneous coronary intervention to be performed in a moment different from immediately after coronary angiography;
Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.

Sites / Locations

Irmandade da Santa Casa de Misericórdia de Marília

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Transradial approach

Transfemoral approach

Arm Description

Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis

Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis

Outcomes

Primary Outcome Measures

First Occurrence of Access Site Related Ischemic or Bleeding Complication

Vascular and systemic complications at arterial puncture site include major bleeding, retroperitoneal hemorrhage, compartment syndrome, hematoma ≥ 5 cm, pseudoaneurysm, arteriovenous fistula, infection, limb ischemia, asymptomatic arterial occlusion, adjacent nerve injury or need for vascular surgery repair.

Secondary Outcome Measures

Adverse Ischemic or Bleeding Events

Individual components of the primary objective, hematoma < 5 cm, cardiovascular death, myocardial infarction, stroke, major bleeding unrelated to puncture site or to coronary artery bypass grafting, device success and crossover rate between techniques

Full Information

NCT ID

NCT01653587

First Posted

July 26, 2012

Last Updated

November 8, 2018

Sponsor

Irmandade Santa Casa Misericórdia Marília

1. Study Identification

Unique Protocol Identification Number

NCT01653587

Brief Title

AngioSeal Versus Radial Approach in Acute Coronary Syndrome

Acronym

ARISE

Official Title

Randomized Trial Between the Transfemoral Approach With AngioSeal and the Transradial Approach to Prevent Vascular Access Complications in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Submitted To Early Invasive Strategy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2016 (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

Among non-ST-segment elevation acute coronary syndrome patients submitted to early invasive strategy and randomized for the transfemoral or transradial approach, the AngioSeal vascular closure device would decrease the prevalence of vascular complications at puncture site, reaching the non-inferiority criterion when compared to the radial access.

Detailed Description

Antithrombotic therapy and percutaneous or surgical myocardial revascularization procedures are the basis of the treatment of patients admitted with non-ST-segment elevation acute coronary syndrome. However, the desired reduction of the recurrence of ischemic events has as complication an increased incidence of bleeding. Since arterial puncture followed by the insertion of an introducer has become the standard method to perform invasive cardiovascular procedures, complications related to vascular access have become an important bleeding site. Among the strategies to decrease vascular complications, the transradial approach is a well stablished alternative to the transfemoral approach. For its part, vascular closure devices were introduced to decrease vascular complications, homeostasis time and ambulation time of patients submitted to invasive procedures by the transfemoral access. Rapidly incorporated to the clinical practice, such devices to date have shown conflicting results with regard to their safety and efficacy. The inconsistency of data proving its safety limits its routine adoption as strategy to prevent vascular complications, requiring evidences through adequately designed randomized studies for this end.

6. Conditions and Keywords

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

Acute Coronary Syndrome

Keywords

Transradial Approach, Transfemoral Approach, Vascular Closure Device

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transradial approach

Arm Type

Active Comparator

Arm Description

Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis

Arm Title

Transfemoral approach

Arm Type

Active Comparator

Arm Description

Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis

Intervention Type

Device

Intervention Name(s)

Percutaneous coronary intervention

Other Intervention Name(s)

AngioSeal vascular closure device, TR Band radial artery compression device

Intervention Description

Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines.

Primary Outcome Measure Information:

Title

First Occurrence of Access Site Related Ischemic or Bleeding Complication

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Adverse Ischemic or Bleeding Events

Description

Time Frame

30 days

Other Pre-specified Outcome Measures:

Title

Cardiovascular Death, Myocardial Infarction or Stroke

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-ST-segment elevation ACS patients [ischemic symptoms suspicious of non-ST-segment elevation ACS (unstable angina or non-ST-segment elevation AMI) defined as clinical presentation compatible with a new manifestation of worsening of chest pain characteristic of ischemia, at rest or at minimum effort, lasting more than 10 minutes, and at least one of the following items: (a) ECG changes compatible with new ischemia (ST segment depression of at least 1 mm, or transient ST segment elevation, or ST segment elevation ≤ 1 mm, or T wave inversion > 2 mm in at least 2 contiguous shunts); (b) cardiac enzymes (CK-MB or troponin T or I) above the upper normality range limit; (c) patients > 60 years of age without ECG or myocardial necrosis markers changes, however with previous documentation of coronary atherosclerotic disease (CAD), confirmed by previous hospitalization due to AMI, previous percutaneous or surgical myocardial revascularization procedure, significant CAD confirmed by coronary angiography, or positive functional test for myocardial ischemia]; Intention to submit patient to early invasive strategy consisting of coronary angiography immediately followed by PCI, when applicable, in the first 72 hours after admission; Signed informed consent; Patient eligible for transradial and transfemoral coronary angiography and PCI, being pre-requisites: (a) palpable radial artery with normal Allen test or/and oximetry tests, (b) familiarity of the operator with the radial and femoral techniques using AngioSeal, (c) 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; Indication of elective percutaneous coronary intervention to be performed in a moment different from immediately after coronary angiography; 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, MD

Organizational Affiliation

Irmandade da Santa Casa de Misericórdia de Marília

Official's Role

Principal Investigator

Facility Information:

Facility Name

Irmandade da Santa Casa de Misericórdia de Marília

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

result

PubMed Identifier

27514319

Citation

Andrade PB, Mattos LA, Rinaldi FS, Bienert IC, Barbosa RA, Labrunie A, Tebet M, Esteves V, Abizaid A, Sousa AR. Comparison of a vascular closure device versus the radial approach to reduce access site complications in non-ST-segment elevation acute coronary syndrome patients: The angio-seal versus the radial approach in acute coronary syndrome trial. Catheter Cardiovasc Interv. 2017 May;89(6):976-982. doi: 10.1002/ccd.26689. Epub 2016 Aug 12.

Results Reference

result

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AngioSeal Versus Radial Approach in Acute Coronary Syndrome

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