Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Coronary Disease, Heart disease, Cardiovascular Diseases, Arteriosclerosis, Atherosclerosis, Manual Compression
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.
Interventions
DEVICEVascular Access Device
AXERA 2 Access System with Reduced Manual Compression
PROCEDUREStandard Manual Compression
Closure procedure by Manual Compression
Sponsors
Borgess Medical Center
Borgess Cardiology Group
Borgess Heart Center for Excellence
Frank Saltiel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Site-Related Major Adverse Events | Up to 37 days post procedure | Observation of any major access site related complications (number of participants). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AXERA 2 Access System Success | At the time of the femoral artey access procedure up to 1 hour post procedure | Achievement of femoral artery access with AXERA and placement of procedural sheath. |
| Time to Hemostasis | From procedural sheath removal until hemostasis is achieved. | Difference between the time the procedural sheath is removed and hemostasis is observed. |
| Time to Actual Discharge | Up to 1 day post procedure | Time following procedural sheath removal until actual discharge. |
| Time to Ambulation | Up to 1 day post procedure | 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. |
| Time to Discharge Eligibility | Up to 1 day post procedure | The time from sheath removal and ambulation to when a subject can be discharged after examination of access site. |
| Minor Access Site Related Complications | Up to 37 days post procedure | Observation of any minor access site related complications. |
| Patient Satisfaction | Up to 37 days post procedure | Assessed by a patient satisfaction questionnaire. |
| Pain Score | Up to 37 days post procedure | — |
| Ability to Sit up at 45-degree Angle | 15 minutes of successful hemostasis | The ability to sit up at a 45-degree angle within 15 minutes of successful hemostasis without rebleed. |
Countries
United States
Participant flow
Pre-assignment details
Thirty-nine patients enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Standard Manual Compression Standard manual compression at the access site applied as per standard of care protocol for sheath removal.
Standard Manual Compression: Closure procedure by Manual Compression | 17 |
| AXERA 2 Access System The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm.
Vascular Access Device: AXERA 2 Access System with Reduced Manual Compression | 22 |
| Total | 39 |
Baseline characteristics
| Characteristic | Standard Manual Compression | AXERA 2 Access System | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 13 Participants | 23 Participants |
| Region of Enrollment United States | 17 Participants | 22 Participants | 39 Participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 2 / 22 |
| serious Total, serious adverse events | 0 / 17 | 0 / 22 |
Outcome results
Primary
Number of Participants With Any Site-Related Major Adverse Events
Observation of any major access site related complications (number of participants).
Time frame: Up to 37 days post procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Manual Compression | Number of Participants With Any Site-Related Major Adverse Events | 0 Participants |
| AXERA 2 Access System | Number of Participants With Any Site-Related Major Adverse Events | 0 Participants |
Secondary
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.
Time frame: 15 minutes of successful hemostasis
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
AXERA 2 Access System Success
Achievement of femoral artery access with AXERA and placement of procedural sheath.
Time frame: At the time of the femoral artey access procedure up to 1 hour post procedure
Population: Data was not analyzed as the device became unavailable and the study was terminated.
Secondary
Minor Access Site Related Complications
Observation of any minor access site related complications.
Time frame: Up to 37 days post procedure
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
Pain Score
Time frame: Up to 37 days post procedure
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
Patient Satisfaction
Assessed by a patient satisfaction questionnaire.
Time frame: Up to 37 days post procedure
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
Time to Actual Discharge
Time following procedural sheath removal until actual discharge.
Time frame: Up to 1 day post procedure
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
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.
Time frame: Up to 1 day post procedure
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
Time to Discharge Eligibility
The time from sheath removal and ambulation to when a subject can be discharged after examination of access site.
Time frame: Up to 1 day post procedure
Population: Data not analyzed as the test device became unavailable and the study was terminated.
Secondary
Time to Hemostasis
Difference between the time the procedural sheath is removed and hemostasis is observed.
Time frame: From procedural sheath removal until hemostasis is achieved.
Population: Data not analyzed as the test device became unavailable and the study was terminated.