Mynx M5 One Hour Ambulation Study

Cardiovascular Associates of the Delaware Valley

Status and phase

Completed

Phase 4

Conditions

Angiography

Treatments

Device: Endovascular Diagnostic Procedures

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01100476

2010 - M5

Details and patient eligibility

About

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

Full description

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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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