NCT02831166

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

3.8 years

First QC Date

July 2, 2016

Last Update Submit

February 10, 2020

Conditions

Myocardial InfarctionComplications; Device, VascularInjury of Radial ArteryInjury; Blood Vessel, Femoral, Artery

Keywords

Vascular closure devicesTransradial approachTransfemoral approach

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours post-procedure

Secondary Outcomes (1)

  • Device success

    48 hours post-procedure

Study Arms (2)

Transradial approach

ACTIVE COMPARATOR

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

Procedure: Transradial primary percutaneous coronary intervention

Transfemoral approach

ACTIVE COMPARATOR

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

Procedure: Transfemoral primary percutaneous coronary intervention

Interventions

Transradial primary percutaneous coronary interventionPROCEDURE

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.

Transradial approach
Transfemoral primary percutaneous coronary interventionPROCEDURE

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.

Transfemoral approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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;
  • Medical, geographic or social conditions impairing the participation in the study or inability to understand and sign the informed consent term.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pedro Beraldo de Andrade

Marília, São Paulo, 17515900, Brazil

Location

Related Publications (1)

  • 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: 24345099BACKGROUND

MeSH Terms

Conditions

Myocardial InfarctionWounds and Injuries

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Pedro B Andrade, phD

    Irmandade SCMM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, phD

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 13, 2016

Study Start

January 1, 2016

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)