ARISTOCRAT-A Randomized Controlled Trial Evaluating Closure Following Access With the AXERA (Device Name) 2 Access System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)

NCT07016698

Peripheral Arterial Disease(PAD)

RECRUITING NA

Nectero EAST System Clinical Study

NCT06001918

Abdominal Aortic Aneurysm

RECRUITING PHASE2/PHASE3

Aortix Therapy for Perioperative Reduction of Kidney Injury

NCT04999163

Acute Kidney Injury

TERMINATED NA

AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft

NCT02480595

Abdominal Aortic Aneurysms

SUSPENDED

ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels

NCT00442065

Abdominal Aortic Aneurysm

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard Manual Compression

Standard manual compression at the access site applied as per standard of care protocol for sheath removal.

Group Type ACTIVE_COMPARATOR

Standard Manual Compression

Intervention Type PROCEDURE

Closure procedure by Manual Compression

AXERA 2 Access System

The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.

Group Type ACTIVE_COMPARATOR

Vascular Access Device

Intervention Type DEVICE

AXERA 2 Access System with Reduced Manual Compression

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vascular Access Device

AXERA 2 Access System with Reduced Manual Compression

Intervention Type DEVICE

Standard Manual Compression

Closure procedure by Manual Compression

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AXERA 2 Access System

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No