Mynx M5 One Hour Ambulation Study

Study Overview
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Brief Summary
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The Mynx Vascular Closure Device (Mynx M5) is a sponge-like material used to close the hole in the artery after patients undergo a diagnostic endovascular procedures

Detailed Description
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Key Inclusion: Patients >18 yrs of age Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery. Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.

Official Title
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Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)

Conditions
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Angiography

Intervention / Treatment
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* Device: Endovascular Diagnostic Procedures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is > 18 years of age Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery Patient has been informed and understands the nature of the study and provides written INformed COnsent approved by the appropriate Institutional Review Board (IRB) prior to enrollment Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by the investigator Exclusion Criteria: Pre-Procedure Exclusion Criteria Patient had a prior surgical procedure, PTA, stent placement, or vascular graft in the common femoral artery Patient has a bleeding disorder such as thrombocytopenia Patient has uncontrolled hypertension Patient is morbidly obese (BMI >40 kg/m2 Patient is pregnant or lactating Patient has a documented INR >1.5 or patients currently receiving glycoprotein IIb/IIIa platelet inhibitor Patient has a known severe allergy to contrast medium Patient has a known allergy to PEG Patient is unable to ambulate at one hour secondary to a co-morbid condition Patient is know to require an extended hospitalization or re-hospitalization (e.g.patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled to have a CABG surgery <30 days following the procedure Intra-Procedure Exclusion Criteria Common femoral artery is <5mm in diameter Patient with clinically significant peripheral vascular disease in the vicinity of the puncture Puncture site is located above the most inferior border of the inferior epigastric artery (IEA) and/or above the inguinal ligament based upon bony landmarks Patient has a posterior puncture or multiple punctures in an attempt to gain access Patient has an ipsilateral venous sheath Patient has a pre-existing arterial bleed/extravasation identified on pre-procedure femoral arteriogram, hematoma, pseudoaneurysm or arteriovenous fistula present prior to sheath removal Patient has intra-procedural bleeding around the access site prior to sheath removal

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular Diagnostic Procedures|Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Tolerability | To assess safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 Closure Device. Participants will be assessed for adverse event occurrence for 30 +/-7 days. | Enrollment approx for 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device success | Assess device success, time to dischargeability, major and minor complications in all patients enrolled in the study | 30 +/- 7days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Closure Device, endovascular procedures, sealing femoral arterial access, Mynx M5