Coronary Artery DiseaseARISTOCRATNCT02061696
ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System
A study testing Vascular Access Device and Standard Manual Compression in people with Coronary Artery Disease, run by Frank Saltiel at 1 site in United States.
Trial summary
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Vascular Access Device and Standard Manual Compression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between 18 and 85 years of age.
- Cardiac catheterization procedure is indicated with involving access through a 5 French (F) or 6 French (F) introducer in the femoral artery.
- Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
- Subject or legally authorized representative has signed informed consent.
Who cannot join
- Subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis)
- Subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure).
- Subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction.
- Extensive calcification of the femoral artery as see on fluoroscopy.
- Subject has systemic hypertension unresponsive to treatment (>180mm Hg systolic and >110mm Hg diastolic).
- Subject has received thrombolytic therapy within the 72 hours prior to catheterization.
Show all 18Show fewer
- Subject has known bleeding disorder,such as Factor 5 deficiency, Idiopathic thrombocytopenic purpura (ITP), thrombasthenia, Von Willebrand's disease.
- Is on warfarin with an International Ratio (INR)>1.5.
- Platelet count is < 100,000.
- Anemia (Hemoglobin <10 g/dl or Hematocrit<30%).
- Subject has compromised femoral artery access site.
- Subject procedure requires an introducer sheath size of > 6 French (F).
- Subject has had prior vascular surgery or vascular grafts at the femoral artery access site.
- Subject presents with hemodynamic instability or is in need of emergent surgery.
- Subject has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days.
- Subject has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of < 1 year.
- Subject is participating in an investigational drug or another device research study that interferes with the current research study endpoints.
- Pregnant or lactating subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression.
Read the detailed description
The study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and PCI.
It is anticipated that the enrollment period for this study will be two years.
The post procedure follow up period is up to 37 days following the procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- Vascular Access Device, Standard Manual Compression
- Keywords
- Coronary Artery Disease, Coronary Disease, Heart disease, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis, Manual Compression
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Access DeviceDevice
Also called AXERA 2 Access System
AXERA 2 Access System with Reduced Manual Compression
Standard Manual CompressionProcedure or surgery
Closure procedure by Manual Compression
| Study group | Role | What they receive |
|---|---|---|
| Standard Manual Compression | Active comparator | Standard manual compression at the access site applied as per standard of care protocol for sheath removal. Receives: Procedure: Standard Manual Compression |
| AXERA 2 Access System | Active comparator | The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm. Receives: Device: Vascular Access Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Site-Related Major Adverse Events
Observation of any major access site related complications (number of participants).
Measured: Up to 37 days post procedure
Secondary outcomes (9)
AXERA 2 Access System Success
Achievement of femoral artery access with AXERA and placement of procedural sheath.
Measured: At the time of the femoral artey access procedure up to 1 hour post procedure
Time to Hemostasis
Difference between the time the procedural sheath is removed and hemostasis is observed.
Measured: From procedural sheath removal until hemostasis is achieved.
Time to Discharge Eligibility
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Measured: Up to 1 day post procedure
Time to Actual Discharge
Time following procedural sheath removal until actual discharge.
Measured: Up to 1 day post procedure
Time to Ambulation
Time from sheath removal until the participant can stand or walk 20 feet without rebleeding. Ambulation can be evaluated at 1,2, and 4 hours post sheath removal until the participant can ambulate.
Measured: Up to 1 day post procedure
Ability to Sit up at 45-degree Angle
The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed.
Measured: 15 minutes of successful hemostasis
Minor Access Site Related Complications
Observation of any minor access site related complications.
Measured: Up to 37 days post procedure
Patient Satisfaction
Assessed by a patient satisfaction questionnaire.
Measured: Up to 37 days post procedure
Pain Score
Measured: Up to 37 days 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 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionJan 2016
Why it stopped: Device was modified and no longer available to investigator
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 (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Saltiel
- Sponsor type
- University, hospital or other
- Collaborators
- Borgess Medical Center, Borgess Cardiology Group, Borgess Heart Center for Excellence
- Responsible party
- Sponsor-investigator, Frank Saltiel, Borgess Research Institute
- Investigators
- Frank Saltiel, MD, Principal investigator, Chairman, Borgess Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061696
- Sponsor's protocol ID
- BRI-001
- Acronym
- ARISTOCRAT
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2014
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Turi ZG, Wortham DC, Sampognaro GC, Kresock FD, Held JS, Smith RD, Veerina KK, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial. J Invasive Cardiol. 2013 Jan;25(1):13-8.
PubMed 23293169
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression
- ClinicalTrials.gov ID
- NCT02061696
- Acronym / sponsor ID
- ARISTOCRAT / BRI-001
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Coronary Disease, Heart disease, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis, Manual Compression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device was modified and no longer available to investigator
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Frank SaltielUniversity, hospital or other
- Collaborators
- Borgess Medical Center, Borgess Cardiology Group, Borgess Heart Center for Excellence
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 18 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the research study is to observe the clinical safety, effectiveness and patient satisfaction of the AXERA 2 Access System in subjects undergoing coronary angiographic and possible Percutaneous Coronary Intervention (PCI) through the femoral artery when compared to standard manual compression.
Detailed description
The study is a single center 1:1 randomized controlled trial in subjects undergoing coronary angiography and PCI.
It is anticipated that the enrollment period for this study will be two years.
The post procedure follow up period is up to 37 days following the procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Manual Compression | Active comparator | Procedure: Standard Manual CompressionStandard manual compression at the access site applied as per standard of care protocol for sheath removal. |
| AXERA 2 Access System | Active comparator | Device: Vascular Access DeviceThe Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is between 18 and 85 years of age.
- Cardiac catheterization procedure is indicated with involving access through a 5 French (F) or 6 French (F) introducer in the femoral artery.
- Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
- Subject or legally authorized representative has signed informed consent.
Key exclusion criteria (18 listed)
- Subject is unable to routinely 20 feet without assistance (e.g. requires a walker or wheelchair to mobilize or has paralysis)
- Subject has an active systemic or cutaneous infection or inflammation (e.g. (septicemia at the time of the procedure).
- Subject undergoing emergent or urgent cardiac catheterization for acute myocardial infarction.
- Extensive calcification of the femoral artery as see on fluoroscopy.
- Subject has systemic hypertension unresponsive to treatment (>180mm Hg systolic and >110mm Hg diastolic).
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 |
|---|---|---|
| Vascular Access DeviceAlso: AXERA 2 Access SystemAXERA 2 Access System with Reduced Manual Compression | Device | AXERA 2 Access System |
| Standard Manual CompressionClosure procedure by Manual Compression | Procedure or surgery | Standard Manual Compression |
Primary outcome
Number of Participants With Any Site-Related Major Adverse Events
Time frame: Up to 37 days post procedure
Observation of any major access site related complications (number of participants).
9 secondary outcomes
AXERA 2 Access System Success
Time frame: At the time of the femoral artey access procedure up to 1 hour post procedure
Time to Hemostasis
Time frame: From procedural sheath removal until hemostasis is achieved.
Time to Discharge Eligibility
Time frame: Up to 1 day post procedure
Time to Actual Discharge
Time frame: Up to 1 day post procedure
Time to Ambulation
Time frame: Up to 1 day post procedure
Ability to Sit up at 45-degree Angle
Time frame: 15 minutes of successful hemostasis
Minor Access Site Related Complications
Time frame: Up to 37 days post procedure
Patient Satisfaction
Time frame: Up to 37 days post procedure
Pain Score
Time frame: Up to 37 days post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23293169Turi ZG, Wortham DC, Sampognaro GC, Kresock FD, Held JS, Smith RD, Veerina KK, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial. J Invasive Cardiol. 2013 Jan;25(1):13-8.
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
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.
Frank Saltiel, MD principal investigator
Chairman, Borgess Heart Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Access Device and Standard Manual Compression in people with Coronary Artery Disease, run by Frank Saltiel at 1 site in United States.
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 18 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: stopped early, as of the sponsor's last update on 23 May 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2017). 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?
Number of Participants With Any Site-Related Major Adverse Events (time frame: Up to 37 days 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 NCT02061696, 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 23 May 2018.