A Randomized Controlled Trial to Assess Safety and Efficacy of AXERA 2 Access System Compared to Manual Compression

Frank Saltiel1 site in 1 country39 target enrollmentJanuary 2014

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Frank Saltiel
Enrollment: 39
Locations: 1
Primary Endpoint: Number of Participants With Any Site-Related Major Adverse Events
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

January 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Frank Saltiel

Responsible Party

Sponsor Investigator

Principal Investigator

Frank Saltiel

Borgess Heart Institute, Chairman

Borgess Research Institute

Eligibility Criteria

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.
•Platelet count is \< 100,
•Anemia (Hemoglobin \<10 g/dl or Hematocrit\<30%).

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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)
AXERA 2 Access System Success(At the time of the femoral artey access procedure up to 1 hour post procedure)
Time to Ambulation(Up to 1 day post procedure)
Ability to Sit up at 45-degree Angle(15 minutes of successful hemostasis)
Minor Access Site Related Complications(Up to 37 days post procedure)
Patient Satisfaction(Up to 37 days post procedure)
Pain Score(Up to 37 days post procedure)