AngioSeal Versus Radial Approach in Acute Coronary Syndrome

NCT01653587 | Completed Phase 4 Results

• 2 other identifiers: ISCMM-01PBA-1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

Transradial Approach; Transfemoral Approach; Vascular Closure Device

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (1)

• Adverse Ischemic or Bleeding Events

  30 days

Other Outcomes (1)

• Cardiovascular Death, Myocardial Infarction or Stroke

  12 months

Study Arms (2)

Transradial approach

ACTIVE COMPARATOR

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

Device: Percutaneous coronary intervention

Transfemoral approach

ACTIVE COMPARATOR

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

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

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.

Also known as: AngioSeal vascular closure device, TR Band radial artery compression device

Transfemoral approach; Transradial approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Irmandade Santa Casa Misericórdia Marília: lead

Study Sites (1)

Irmandade da Santa Casa de Misericórdia de Marília

Marília, São Paulo, 17515900, Brazil

Location

Related Publications (2)

• 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.

  PMID: 24345099 RESULT

• 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.

  PMID: 27514319 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Dr. Pedro Beraldo de Andrade
• Organization: Santa Casa de Marília

pedroberaldo@gmail.com

+551434025561

Study Officials

• Pedro B Andrade, MD

  Irmandade da Santa Casa de Misericórdia de Marília

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 31, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 5, 2018
• Results First Posted: October 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)