Not provided
Not provided
Not provided
Not provided
Device was modified and no longer available to investigator
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Borgess Medical Center | UNKNOWN |
| Borgess Cardiology Group | UNKNOWN |
| Borgess Heart Center for Excellence | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Manual Compression | Active Comparator | Standard manual compression at the access site applied as per standard of care protocol for sheath removal. |
|
| AXERA 2 Access System | Active Comparator | The Vascular Access device used is the AXERA 2 Access System for patients randomized to this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Access Device | Device | AXERA 2 Access System with Reduced Manual Compression |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AXERA 2 Access System Success | Achievement of femoral artery access with AXERA and placement of procedural sheath. | At the time of the femoral artey access procedure up to 1 hour post procedure |
| Time to Hemostasis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frank Saltiel, MD | Chairman, Borgess Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Borgess Medical Center | Kalamazoo | Michigan | 49048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23293169 | Background | 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. |
Not provided
Not provided
Thirty-nine patients enrolled in the study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | AXERA 2 Access System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Any Site-Related Major Adverse Events | Observation of any major access site related complications (number of participants). | Posted | Count of Participants | Participants | Up to 37 days post procedure |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Vascular disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank Saltiel, MD | Borgess Heart Institute | 269-381-3963 |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard Manual Compression | Procedure | Closure procedure by Manual Compression |
|
Difference between the time the procedural sheath is removed and hemostasis is observed.
| 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. | Up to 1 day post procedure |
| Time to Actual Discharge | Time following procedural sheath removal until actual discharge. | 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. | 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. | 15 minutes of successful hemostasis |
| Minor Access Site Related Complications | Observation of any minor access site related complications. | Up to 37 days post procedure |
| Patient Satisfaction | Assessed by a patient satisfaction questionnaire. | Up to 37 days post procedure |
| Pain Score | Up to 37 days post procedure |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | AXERA 2 Access System Success | Achievement of femoral artery access with AXERA and placement of procedural sheath. | Data was not analyzed as the device became unavailable and the study was terminated. | Posted | At the time of the femoral artey access procedure up to 1 hour post procedure |
|
|
| Secondary | Time to Hemostasis | Difference between the time the procedural sheath is removed and hemostasis is observed. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | From procedural sheath removal until hemostasis is achieved. |
|
|
| Secondary | Time to Discharge Eligibility | The time from sheath removal and ambulation to when a subject can be discharged after examination of access site. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | Up to 1 day post procedure |
|
|
| Secondary | Time to Actual Discharge | Time following procedural sheath removal until actual discharge. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | Up to 1 day post procedure |
|
|
| 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. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | Up to 1 day post procedure |
|
|
| 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. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | 15 minutes of successful hemostasis |
|
|
| Secondary | Minor Access Site Related Complications | Observation of any minor access site related complications. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | Up to 37 days post procedure |
|
|
| Secondary | Patient Satisfaction | Assessed by a patient satisfaction questionnaire. | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | Up to 37 days post procedure |
|
|
| Secondary | Pain Score | Data not analyzed as the test device became unavailable and the study was terminated. | Posted | Up to 37 days post procedure |
|
|
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | 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 | 0 | 22 | 2 | 22 |
| Discomfort and paresthesia in groin | Injury, poisoning and procedural complications | Systematic Assessment |
|
Not provided
Not provided