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The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic Procedure | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic catheterization procedure | Device | Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events. | Procedure through 30 days follow-up. | |
| Major Adverse Events Reported as Percentage of Participants With Adverse Events. | Observation of any major access site-related complication (percentage of participants). | Procedure through 30 day follow-up. |
| Device Success | Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery. | Procedure |
| Minor Adverse Events | Observation of any minor access site-related complications. | Procedure through 30 day follow-up. |
| Time to Hemostasis | The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed. | Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved. |
| Time to Discharge Eligibility | The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site. | Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site. |
| Time to Actual Discharge | The time from sheath removal to actual hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression. | Hemostasis was evaluated immediately following procedural sheath removal. |
| Time to Ambulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zoltan Turi, MD | The Cooper Health System | Principal Investigator |
| John Held, MD | Mercy Hospital Fairfield | Principal Investigator |
| Frank Kresock, MD | The Cardiovascular Center | Principal Investigator |
| Tom Hinohara, MD | Sequoia Hospital | Principal Investigator |
| Dale Wortham, MD | Volunteer Research Group, LLC | Principal Investigator |
| Greg Sampognaro, MD | P&S | Principal Investigator |
| Ray Smith, MD | Ark-La-Tex Cardiology/Willis-Knighton Hospital | Principal Investigator |
| Kalyan Veerina, MD | Cardiovascular Institute of the South-Opelousas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cardiovascular Center | Parker | Arizona | 85344 | United States | ||
| Sequoia Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23293169 | Derived | 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. |
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Patients were required to be able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
Enrollment commenced November 3, 2010 and concluded June 3, 2011. Patients who underwent routine diagnostic catheterization through 5 or 6F sheaths were enrolled in the study at 8 investigational sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intent to Treat (ITT) | The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful. |
| FG001 | Sheath Greater Than 6 French (F) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours. |
| Time to Ambulation | Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding. | Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. |
| Percentage of Participants With Bed Elevation Within 15 Minutes. | Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects. | Post procedure |
Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression. |
| Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. |
| Redwood City |
| California |
| 94062 |
| United States |
| P&S Surgical Hospital | Monroe | Louisiana | 71201 | United States |
| Cardiovascular Institute of the South-Opelousas | Opelousas | Louisiana | 70570 | United States |
| Willis-Knighton Hospital | Shreveport | Louisiana | 71103 | United States |
| The Cooper Health System | Camden | New Jersey | 08103 | United States |
| Mercy Hospital Fairfield | Fairfield | Ohio | 45014 | United States |
| Volunteer Research Group, LLC | Knoxville | Tennessee | 37920 | United States |
Subjects in whom the procedural sheath was upsized to greater than 6F. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intent to Treat | |
| BG001 | Sheath Greater Than 6F | |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events. | Not Posted | Procedure through 30 days follow-up. | ||||||||||||||||||||||||||||||||||||
| Primary | Major Adverse Events Reported as Percentage of Participants With Adverse Events. | Observation of any major access site-related complication (percentage of participants). | Posted | Number | Percentage of participants | Procedure through 30 day follow-up. |
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| Primary | Device Success | Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery. | Intent to treat. | Posted | Number | Percentage of participants | Procedure |
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| Primary | Minor Adverse Events | Observation of any minor access site-related complications. | Posted | Number | Percentage of participants | Procedure through 30 day follow-up. |
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| Primary | Time to Hemostasis | The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed. | Per protocol. | Posted | Mean | Standard Deviation | Minutes | Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved. |
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| Primary | Time to Discharge Eligibility | The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site. | Per Protocol. | Posted | Mean | Standard Deviation | Hours | Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site. |
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| Primary | Time to Actual Discharge | The time from sheath removal to actual hospital discharge. | Per protocol. | Posted | Mean | Standard Deviation | Hours | Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours. |
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| Primary | Time to Ambulation | Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding. | Per protocol. | Posted | Mean | Standard Deviation | Hours | Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. |
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| Primary | Percentage of Participants With Bed Elevation Within 15 Minutes. | Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects. | Per protocol. | Posted | Number | Percentage of participants | Post procedure |
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| Secondary | Time to Hemostasis | Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression. | Per protocol-Diagnostic Cohort. | Posted | Mean | Standard Deviation | Minutes | Hemostasis was evaluated immediately following procedural sheath removal. |
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| Secondary | Time to Ambulation | Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression. | Per Protocol-Diagnostic Cohort. | Posted | Mean | Standard Deviation | Hours | Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated. |
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Procedure through 30 day post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intent to Treat | 0 | 346 | 0 | 346 | |||
| EG001 | Sheath Greater Than 6F | 0 | 5 | 0 | 5 |
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Prior to submission for publication or presentation, the Institution will provide the Sponsor with at least sixty (60) days for review of a manuscript. If requested in writing,The Institution and Principal Investigator will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Cogan, Director of Quality, Regulatory and Clinical | Arstasis | 650-261-8073 | dcogan@arstasis.com |
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| Male |
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