ARISE: AngioSeal Versus Radial Approach in Acute Coronary Syndrome

• Sponsor: Irmandade Santa Casa Misericórdia Marília (Other)
• Overall Status: Completed
• CT.gov ID: NCT01653587
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Device: Percutaneous coronary intervention	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Mar 1, 2015
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. First Occurrence of Access Site Related Ischemic or Bleeding Complication [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.

Secondary Outcome Measures

1. Adverse Ischemic or Bleeding Events [30 days]

   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

1. Cardiovascular Death, Myocardial Infarction or Stroke [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Irmandade da Santa Casa de Misericórdia de Marília	Marília	São Paulo	Brazil	17515900

Sponsors and Collaborators

• Irmandade Santa Casa Misericórdia Marília

Investigators

• Principal Investigator: Pedro B Andrade, MD, Irmandade da Santa Casa de Misericórdia de Marília

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pedro Beraldo de Andrade, MD, Irmandade Santa Casa Misericórdia Marília
• ClinicalTrials.gov Identifier: NCT01653587
• Other Study ID Numbers: ISCMM-01; PBA-1
• First Posted: Jul 31, 2012
• Last Update Posted: Dec 5, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pedro Beraldo de Andrade, MD, Irmandade Santa Casa Misericórdia Marília: Transradial Approach; Transfemoral Approach; Vascular Closure Device
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome

Study Results

Participant Flow

Arm/Group Title	Transradial Approach	Transfemoral Approach
Arm/Group Description	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis 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.	Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis 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.
Period Title: Overall Study
STARTED	120	120
COMPLETED	120	120
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Transradial Approach	Transfemoral Approach	Total
Arm/Group Description	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis 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.	Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis 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.	Total of all reporting groups
Overall Participants	120	120	240
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	65 54.2%	67 55.8%	132 55%
>=65 years	55 45.8%	53 44.2%	108 45%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (11.2)	63.6 (10.2)	63.0 (10.7)
Sex: Female, Male (Count of Participants)
Female	40 33.3%	24 20%	64 26.7%
Male	80 66.7%	96 80%	176 73.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	120 100%	120 100%	240 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	120 100%	120 100%	240 100%
Region of Enrollment (participants) [Number]
Brazil	120 100%	120 100%	240 100%

Outcome Measures

1. Primary Outcome

Title	First Occurrence of Access Site Related Ischemic or Bleeding Complication
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transradial Approach	Transfemoral Approach
Arm/Group Description	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis 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.	Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis 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.
Measure Participants	120	120
Count of Participants [Participants]	16 13.3%	15 12.5%

2. Secondary Outcome

Title	Adverse Ischemic or Bleeding Events
Description	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
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transradial Approach	Transfemoral Approach
Arm/Group Description	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis 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.	Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis 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.
Measure Participants	120	120
Count of Participants [Participants]	11 9.2%	3 2.5%

3. Other Pre-specified Outcome

Title	Cardiovascular Death, Myocardial Infarction or Stroke
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Transradial Approach	Transfemoral Approach
Arm/Group Description	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis 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.	Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis 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.
Measure Participants	120	120
Count of Participants [Participants]	2 1.7%	3 2.5%

Adverse Events

Arm/Group Title	Transradial Approach		Transfemoral Approach
Arm/Group Description	Transradial approach percutaneous coronary intervention using the TR Band device to obtain hemostasis 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.		Transfemoral approach percutaneous coronary intervention using the AngioSeal vascular closure device STS Plus Platform to obtain hemostasis 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.
All Cause Mortality
	Transradial Approach		Transfemoral Approach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/120 (1.7%)		2/120 (1.7%)
Serious Adverse Events
	Transradial Approach		Transfemoral Approach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/120 (2.5%)		9/120 (7.5%)
Cardiac disorders
Cardiovascular death	0/120 (0%)	0	2/120 (1.7%)	2
Periprocedural myocardial infarction	2/120 (1.7%)	2	4/120 (3.3%)	4
General disorders
Nervous system disorders
Stroke	0/120 (0%)	0	1/120 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Transradial Approach		Transfemoral Approach
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/120 (1.7%)		2/120 (1.7%)
Vascular disorders
Major bleeding	2/120 (1.7%)	2	2/120 (1.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.