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

NCT02061696 | Terminated Results

• 1 other identifier: BRI-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Coronary Disease; Heart disease; Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis; Manual Compression

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Site-Related Major Adverse Events

  Observation of any major access site related complications (number of participants).

  Up to 37 days post procedure

Secondary Outcomes (9)

• AXERA 2 Access System Success

  At the time of the femoral artey access procedure up to 1 hour post procedure

• Time to Hemostasis

  From procedural sheath removal until hemostasis is achieved.

• Time to Discharge Eligibility

  Up to 1 day post procedure

• Time to Actual Discharge

  Up to 1 day post procedure

• Time to Ambulation

  Up to 1 day post procedure

Study Arms (2)

Standard Manual Compression

ACTIVE COMPARATOR

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

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.

Device: Vascular Access Device

Interventions

Vascular Access Device DEVICE

AXERA 2 Access System with Reduced Manual Compression

Also known as: AXERA 2 Access System

AXERA 2 Access System

Standard Manual Compression PROCEDURE

Closure procedure by Manual Compression

Standard Manual Compression

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frank Saltiel: lead
• Borgess Medical Center: collaborator
• Borgess Cardiology Group: collaborator
• Borgess Heart Center for Excellence: collaborator

Study Sites (1)

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Related Publications (1)

• 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.

  PMID: 23293169 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Atherosclerosis

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Limitations and Caveats

The test device was modified and no longer available to the investigator and the study was terminated. Because of this, secondary outcomes were not analyzed.

Results Point of Contact

• Title: Frank Saltiel, MD
• Organization: Borgess Heart Institute

269-381-3963

Study Officials

• Frank Saltiel, MD

  Chairman, Borgess Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Borgess Heart Institute, Chairman

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 13, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 23, 2018
• Results First Posted: August 18, 2017

Record last verified: 2018-04

Locations

US (1)