- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271946
A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System (RECITAL)
January 23, 2013 updated by: Arstasis, Inc.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
351
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Parker, Arizona, United States, 85344
- The Cardiovascular Center
-
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California
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Redwood City, California, United States, 94062
- Sequoia Hospital
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Louisiana
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Monroe, Louisiana, United States, 71201
- P&S Surgical Hospital
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Opelousas, Louisiana, United States, 70570
- Cardiovascular Institute of the South-Opelousas
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Shreveport, Louisiana, United States, 71103
- Willis-Knighton Hospital
-
-
New Jersey
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Camden, New Jersey, United States, 08103
- The Cooper Health System
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Ohio
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Fairfield, Ohio, United States, 45014
- Mercy Hospital Fairfield
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Tennessee
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Knoxville, Tennessee, United States, 37920
- Volunteer Research Group, LLC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is between 18 and 85 years of age.
- Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
- Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.
Exclusion Criteria:
- Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
- Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
- Patient has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mmHg diastolic).
- Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
- Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count <100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin< 10 g/dL, or Hct<30%).
- Patient has a compromised femoral artery access site.
- Patient procedure requires an introducer sheath size of> 6F.
- Patient has had prior vascular surgery or vascular grafts at the femoral artery access site.
- Patient presents with hemodynamic instability or is in need of emergent surgery.
- Patient has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days of the current procedure.
- Patient has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of< 30 dys or for other reasons has a life expectancy of less than 1 yaer.
- Patient is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
- Pregnant or lactating patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Diagnostic Procedure
|
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Time Frame: Procedure through 30 days follow-up.
|
Procedure through 30 days follow-up.
|
|
Major Adverse Events Reported as Percentage of Participants With Adverse Events.
Time Frame: Procedure through 30 day follow-up.
|
Observation of any major access site-related complication (percentage of participants).
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Procedure through 30 day follow-up.
|
Device Success
Time Frame: Procedure
|
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
Time Frame: Procedure through 30 day follow-up.
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Observation of any minor access site-related complications.
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Procedure through 30 day follow-up.
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Time to Hemostasis
Time Frame: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
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The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
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Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
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Time to Discharge Eligibility
Time Frame: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
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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.
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Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
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Time to Actual Discharge
Time Frame: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
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The time from sheath removal to actual hospital discharge.
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Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
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Time to Ambulation
Time Frame: 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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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.
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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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Percentage of Participants With Bed Elevation Within 15 Minutes.
Time Frame: Post procedure
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Hemostasis
Time Frame: Hemostasis was evaluated immediately following procedural sheath removal.
|
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
Time Frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
|
Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.
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Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
January 5, 2011
First Submitted That Met QC Criteria
January 5, 2011
First Posted (Estimate)
January 7, 2011
Study Record Updates
Last Update Posted (Estimate)
January 31, 2013
Last Update Submitted That Met QC Criteria
January 23, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- RC-03133
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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