Mynx M5 One Hour Ambulation Study (Mynx)

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

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

Study Overview

• Status: Completed
• Conditions: Angiography
• Intervention / Treatment: Device: Endovascular Diagnostic Procedures

Detailed Description

Key Inclusion:

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

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Our Lady of Lourdes Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cardiovascular Associates of the Delaware Valley
• Collaborators: AccessClosure, Inc.
• Investigators: Principal Investigator: Vijay K Verma, MD, Cardiovascular Associates of the Delaware Valley; Study Director: Mary F Kinder, RN, BSN, Cardiovascular Associates of the Delaware Valley

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: April 5, 2010
• First Submitted That Met QC Criteria: April 8, 2010
• First Posted (Estimate): April 9, 2010

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Closure Device; endovascular procedures; sealing femoral arterial access; Mynx M5
• Other Study ID Numbers: 2010 - M5