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AngioSeal Versus Radial Approach in Acute Coronary Syndrome (ARISE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Irmandade Santa Casa Misericórdia Marília
Sponsor:
Information provided by (Responsible Party):
Pedro Beraldo de Andrade, Irmandade Santa Casa Misericórdia Marília
ClinicalTrials.gov Identifier:
NCT01653587
First received: July 26, 2012
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Device: Percutaneous coronary intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Further study details as provided by Irmandade Santa Casa Misericórdia Marília:

Primary Outcome Measures:
  • First occurrence of access site related ischemic or bleeding complication [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • Cardiovascular death, myocardial infarction or stroke [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: July 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transradial approach
Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis
Device: Percutaneous coronary intervention
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.
Other Names:
  • AngioSeal vascular closure device
  • TR Band radial artery compression device
Active Comparator: Transfemoral approach
Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis
Device: Percutaneous coronary intervention
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.
Other Names:
  • AngioSeal vascular closure device
  • TR Band radial artery compression device

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653587

Contacts
Contact: Pedro B Andrade, MD +55 1434548968 pedroberaldo@gmail.com
Contact: Mônica A Andrade +55 1434025561 monicaathanazio@gmail.com

Locations
Brazil
Irmandade da Santa Casa de Misericórdia de Marília Recruiting
Marília, São Paulo, Brazil, 17515900
Contact: Pedro B Andrade, MD    +551434548968    pedroberaldo@gmail.com   
Contact: Mônica A Andrade, RN    +551434025561    monicaathanazio@gmail.com   
Principal Investigator: Pedro B Andrade, MD         
Sub-Investigator: Marden A Tebet, MD         
Sub-Investigator: Ederlon F Nogueira, MD         
Sub-Investigator: Vinícius C Esteves, MD         
Sub-Investigator: André Labrunie, MD, phD         
Sub-Investigator: Luiz P Mattos, MD, phD         
Sponsors and Collaborators
Irmandade Santa Casa Misericórdia Marília
Investigators
Principal Investigator: Pedro B Andrade, MD Irmandade da Santa Casa de Misericórdia de Marília
  More Information

Publications:
Responsible Party: Pedro Beraldo de Andrade, MD, Irmandade Santa Casa Misericórdia Marília
ClinicalTrials.gov Identifier: NCT01653587     History of Changes
Other Study ID Numbers: ISCMM-01, PBA-1
Study First Received: July 26, 2012
Last Updated: August 21, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Irmandade Santa Casa Misericórdia Marília:
Transradial Approach
Transfemoral Approach
Vascular Closure Device

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014