Clinical trial NCT01100476: Mynx M5 One Hour Ambulation Study
Official title: Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Angiography
Keywords: Closure Device
endovascular procedures
sealing femoral arterial access
Mynx M5
Lead sponsor: Cardiovascular Associates of the Delaware Valley
Sponsor class: OTHER
Collaborators: name: AccessClosure, Inc.
First posted: 2010-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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:

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

Primary outcomes:
measure: Safety & Tolerability
timeFrame: Enrollment approx for 4 months
Secondary outcomes:
measure: Device success
timeFrame: 30 +/- 7days
Other outcomes:
Locations:
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
Study officials:
affiliation: Cardiovascular Associates of the Delaware Valley
name: Vijay K Verma, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Associates of the Delaware Valley
name: Mary F Kinder, RN, BSN
role: STUDY_DIRECTOR
References: