Myocardial InfarctionPhase 4ARISE-2NCT02831166
Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
A Phase 4 study testing Transradial primary percutaneous coronary intervention and Transfemoral primary percutaneous coronary intervention in people with Myocardial Infarction and Complications; Device, Vascular, run by Irmandade Santa Casa Misericórdia Marília at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Complications; Device, Vascular, Injury of Radial Artery
- What is being tested?
- Transradial primary percutaneous coronary intervention and Transfemoral primary percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2016to Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 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.
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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
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.
- Conditions
- Myocardial Infarction, Complications; Device, Vascular, Injury of Radial Artery, Injury; Blood Vessel, Femoral, Artery
- Being tested
- Transradial primary percutaneous coronary intervention, Transfemoral primary percutaneous coronary intervention
- Keywords
- Vascular closure devices, Transradial approach, Transfemoral approach
- Medical subject headings
- Myocardial Infarction, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial primary percutaneous coronary interventionProcedure or surgery
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.
Transfemoral primary percutaneous coronary interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transradial approach | Active comparator | Transradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125). Receives: 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). Receives: Procedure: Transfemoral primary percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours post-procedure
Secondary outcomes (1)
Device success
The success of the device is defined as the attainment of adequate hemostasis at the end of the procedure, without the need to apply other compression methods.
Measured: 48 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade Santa Casa Misericórdia Marília
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Beraldo de Andrade, Irmandade Santa Casa Misericórdia Marília
- Investigators
- Pedro B Andrade, phD, Principal investigator, Irmandade SCMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831166
- Sponsor's protocol ID
- 50120915.1.0000.5413
- Acronym
- ARISE-2
- Status last verified
- Feb 2020
- First submitted
- 2 Jul 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison Between Transfemoral Approach With Vascular Closure Device Versus Transradial Approach in Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02831166
- Acronym / sponsor ID
- ARISE-2 / 50120915.1.0000.5413
- Conditions
- Myocardial Infarction, Complications; Device, Vascular, Injury of Radial Artery, Injury; Blood Vessel, Femoral, Artery
- Keywords
- Vascular closure devices, Transradial approach, Transfemoral approach
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Irmandade Santa Casa Misericórdia MaríliaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial approach | Active comparator | Procedure: Transradial primary percutaneous coronary interventionTransradial approach primary percutaneous coronary intervention using the TR Band device to obtain hemostasis (n=125). |
| Transfemoral approach | Active comparator | Procedure: Transfemoral primary percutaneous coronary interventionTransfemoral approach primary percutaneous coronary intervention using a vascular closure device to obtain hemostasis (n=125). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 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 |
|---|---|---|
| Transradial primary percutaneous coronary interventionTransradial 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. | Procedure or surgery | Transradial approach |
| Transfemoral primary percutaneous coronary interventionTransfemoral 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. | Procedure or surgery | Transfemoral approach |
Primary outcome
Major vascular access site complications
Time frame: 48 hours post-procedure
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.
1 secondary outcome
Device success
Time frame: 48 hours post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: 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.
- 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, phD principal investigator
Irmandade SCMM
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 Transradial primary percutaneous coronary intervention and Transfemoral primary percutaneous coronary intervention in people with Myocardial Infarction and Complications; Device, Vascular, 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 12 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 11 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major vascular access site complications (time frame: 48 hours post-procedure). 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 NCT02831166, which also lists 1 linked publication.
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 11 Feb 2020.