Mynx M5 One Hour Ambulation Study

NCT ID: NCT01100476

Last Updated: 2013-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-08-31

Brief Summary

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

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.

Conditions

Angiography

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Endovascular Diagnostic Procedures

Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery

Intervention Type: DEVICE

Other Intervention Names

Angiography

Eligibility Criteria

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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AccessClosure, Inc.

INDUSTRY

Sponsor Role: collaborator

Cardiovascular Associates of the Delaware Valley

OTHER

Sponsor Role: lead

Responsible Party

Vijayendra K. Verma, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vijay K Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Associates of the Delaware Valley

Mary F Kinder, RN, BSN

Role: STUDY_DIRECTOR

Cardiovascular Associates of the Delaware Valley

Locations

Our Lady of Lourdes Medical Center

Camden, New Jersey, United States

Countries

United States

Other Identifiers

2010 - M5

Identifier Type: -

Identifier Source: org_study_id