Acute Coronary SyndromePhase 4ARISENCT01653587

AngioSeal Versus Radial Approach in Acute Coronary Syndrome

A Phase 4 study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome, run by Irmandade Santa Casa Misericórdia Marília at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Percutaneous coronary intervention
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteBrazil
Study dates: Jul 2012to Mar 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Irmandade da Santa Casa de Misericórdia de Marília
Marília, São Paulo, 17515900

Other trials in Brazil

About this study

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

Read the 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.

Conditions: Acute Coronary Syndrome
Being tested: Percutaneous coronary intervention
Keywords: Transradial Approach, Transfemoral Approach, Vascular Closure Device
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Percutaneous coronary interventionDevice
Also called AngioSeal vascular closure device, TR Band radial artery compression 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.

Study groups in NCT01653587
Study group	Role	What they receive
Transradial approach	Active comparator	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis Receives: 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 Receives: Device: Percutaneous coronary intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 30 days

Secondary outcomes (1)

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
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Mar 2016

First posted31 Jul 2012 (estimated)
Study startJul 2012
Primary completionMar 2015
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01653587
Sponsor's protocol ID: ISCMM-01
Other IDs: PBA-1
Acronym: ARISE
Status last verified: Nov 2018
First submitted: 26 Jul 2012
Last updated: 5 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 24345099
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.
PubMed 27514319

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Coronary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01653587
Acronym / sponsor ID: ARISE / ISCMM-01
Conditions: Acute Coronary Syndrome
Keywords: Transradial Approach, Transfemoral Approach, Vascular Closure Device
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Irmandade Santa Casa Misericórdia MaríliaUniversity, hospital or other
Study start: Jul 2012
Primary completion: Mar 2015 (actual)
Study completion: Mar 2016 (actual)
First posted: 31 Jul 2012 (estimated)
Results: Posted 9 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Transradial approach	Active comparator	Device: Percutaneous coronary interventionTransradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis
Transfemoral approach	Active comparator	Device: Percutaneous coronary interventionTransfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (13 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Percutaneous coronary interventionAlso: AngioSeal vascular closure device, TR Band radial artery compression deviceBoth 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.	Device	Transfemoral approach, Transradial approach

Primary outcome

First Occurrence of Access Site Related Ischemic or Bleeding Complication
Time frame: 30 days
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.

1 secondary outcome

Adverse Ischemic or Bleeding Events
Time frame: 30 days

Results and safety

Results posted to the registry on 9 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transradial Approach	120	120
Transfemoral Approach	120	120

Primary outcome: First Occurrence of Access Site Related Ischemic or Bleeding Complication

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Transradial Approach n = 120	Transfemoral Approach n = 120
Value	16	15

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transradial Approach	3 of 120 (2.5%)	2 of 120 (1.7%)	2 of 120
Transfemoral Approach	9 of 120 (7.5%)	2 of 120 (1.7%)	2 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24345099de 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 publication: PubMed 27514319Andrade 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pedro B Andrade, MD principal investigator

Irmandade da Santa Casa de Misericórdia de Marília

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Percutaneous coronary intervention in people with Acute Coronary Syndrome, run by Irmandade Santa Casa Misericórdia Marília at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First Occurrence of Access Site Related Ischemic or Bleeding Complication (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01653587, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.