A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

Study Overview
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Brief Summary
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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.

Official Title
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A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

Conditions
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Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer

Intervention / Treatment
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* Device: Diagnostic catheterization procedure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Diagnostic Procedure<br> | Device: Diagnostic catheterization procedure<br>* Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |