The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Phase: PHASE4
Conditions: Cardiac Diagnostic Procedure, Cardiac Interventional Procedure, Femoral Access Site Closure
Sponsor: Medstar Health Research Institute

The Safety and Efficacy of an Extravascular, 
Water-Soluble Sealant for Venous Access-site Closure 
1 
 
 
 
 
 
The Safety and Effectiveness of Polyethylene Glycol 
Sealant for Femoral Venous Access-site Closure 
 
 
SPONSOR: 
 
 
 
MEDSTAR CARDIOVASCULAR RESEARCH NETWORK 
 
 
 
 
 
 
 
 
VERSION: 
 
 
 
1.2 
 
 
 
ISSUE DATE:  
 
 
JULY 2014 
 
 
 
STATUS:  
 
 
 
SYNPOSIS 
 
 
 
PRIMARY INVESTIGATOR:  
 
RON WAKSMAN, MD 
 
DIRECTOR, CARDIOVASCULAR RESEARCH NETWORK 
 
 
 
 
 
WASHINGTON HOSPITAL CENTER 
 
 
 
 
 
110 IRVING STREET NW, SUITE 4B-1 
WASHINGTON, DC 20010 
 
 
 
 
 
202-877-8575 
 
 
 
 
 
RON.WAKSMAN@MEDSTAR.NET 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

The Safety and Efficacy of an Extravascular, 
Water-Soluble Sealant for Venous Access-site Closure 
2 
 
Introduction:  
 
Over 5 million central venous catheters are placed each year in the United States 1. 
Such procedures are often done without direct visualization of the vessel wall, which 
risks vessel damage and bleeding. Vascular closure devices (VCDs) offer the potential 
for enhanced control of access-site hemostasis and reduced complications in 
comparison with manual compression. VCDs have shown to reduce time to ambulation, 
increase patient comfort, accelerate time to discharge, and, for patients undergoing 
diagnostic angiography, reduced bleeding complications compared with manual 
compression 2, 3. 
 
Two principal reasons exist for using a VCD, namely to improve the safety and to 
enhance the efficacy of the percutaneous procedure. The MynxGripGrip™ Vascular 
Closure Device (AccessClosure, Inc, Santa Clara, CA) has previously demonstrated 
both of these features when used for arterial access-site closure 4. In this study, major 
complications occurred in 0.5% of patients and the device allowed for rapid hemostasis 
(1.3 minutes) independent of anticoagulation use. The MynxGrip VCD received Food 
and Drug Administration (FDA) approval in 2007 for arterial access closure.  
 
With increasing volume and complexity of cardiac interventional procedures requiring 
venous access, venous hemostasis and subsequent groin complications are a 
significant concern. The MynxGrip VCD appears to be an excellent choice for venous 
closure due to its extravascular use of a water-soluble, polyethyleneglycol matrix. In a 
recent large, single center study, propensity score-matched analysis, the MynxGrip 
device was successfully deployed in the femoral vein for immediate hemostasis. Results 
showed consistent safety and efficacy, similar to arterial device deployment, with low 
complication rates (<1%) and no major bleeding events. Importantly, no vessel injury or 
deep vein thrombosis were noted 5. The ability to achieve rapid and reliable venous 
hemostasis following either a diagnostic or interventional procedure appears feasible, 
although no device has FDA approval for such an indication.    
 
STUDY AIM 
This study is aimed to assess safety of the MynxGrip™ Vascular Closure Device (VCD) 
[AccessClosure, Mountain View, CA] system for venous access site hemostasis 
following diagnostic and interventional procedures.   
 
HYPOTHESIS 
1. The MynxGrip™ Vascular Closure Device is as safe as manual compression for 
venous hemostasis following diagnostic or interventional procedures.  
OBJECTIVES 
PRIMARY 
1. Evaluate the safety of the MynxGrip extravascular sealant for common femoral vein 
closure following both diagnostic and interventional procedures as assessed by 
clinical and imaging criteria.  
ENDPOINTS 

The Safety and Efficacy of an Extravascular, 
Water-Soluble Sealant for Venous Access-site Closure 
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PRIMARY 
The primary safety endpoint will include both deep venous thrombotic and 
bleeding/vascular injury related complications prior to discharge and at 1 week follow-
up. Outcomes will be assessed via clinical evaluation and imaging with clinically 
indicated as follow:   
 Assessment of venous thrombosis 
i. Clinical: Physical exam findings consistent with venous 
thrombotic/thromboembolic related complication:  
o Redness or swelling at the venous puncture site  
o Increased lower extremity edema  
o Calf pain 
o New onset or worsening shortness of breath  
o New onset of pleuritic chest pain 
ii. and if clinically indicated, imaging: venous Doppler ultrasound 
assessment of obstructive or non-obstructive deep vein thrombosis 
(DVT) 
 Bleeding or vascular related complications 
i. 
Damage to the vessel requiring surgical repair  
ii. 
Access site bleeding requiring the need for transfusion  
iii. 
Nerve injury at access site  
iv. 
Generalized infection (septicemia with typical signs, symptoms and 
positive blood cultures shortly after the index procedure, and 
requiring treatment with intravenous (IV) antibiotics)Pseudo-
aneurysms requiring invasive treatment 
 Device/procedure failure 
Device failure is defined as either the inability to deploy the device or 
device deployment with inadequate hemostasis requiring conversion to 
immediate manual pressure, or the eventual need for alternative 
methods to obtain hemostasis. 
 
.Efficacy will be assessed by time to hemostasis: 
Time to hemostasis is defined as the time from advancer tube removal 
(i.e., device removal) to the time when hemostasis was first observed. 
 
STUDY POPULATION 
NUMBER OF SUBJECTS 
A total of 208 patients undergoing either diagnostic or interventional procedures will be 
enrolled into this trial. 
 
ELIGIBILITY OF SUBJECTS 
GENERAL INCLUSION CRITERIA 

The Safety and Efficacy of an Extravascular, 
Water-Soluble Sealant for Venous Access-site Closure 
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Patients > 18 years of age scheduled for a percutaneous diagnostic or interventional 
procedure that have either a 5, 6, or 7F sheath placed in the common femoral vein. 
EXCLUSION CRITERIA 
1. Patient has a history of a bleeding disorder  
2. Previous history of venous thrombosis or thromboembolism  
3. Patient is pregnant or lactating 
4. Patient has a known severe allergy to contrast medium 
5. Patient has a known allergy to PEG 
7. 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) 
9. Multiple (>1) attempts at venous access were attempted  
10. Patient has intra-procedural bleeding around the access site prior to sheath removal 
11. Critically ill patients requiring intravenous vasopressors for blood pressure 
stabilization  
12. Ipsilateral femoral artery puncture or sheath insertion 
13. Glycoprotein IIb/IIIIa use 
14. Any bleeding or vascular access-site complication evident pre-venous closure   
 
 
STUDY DESIGN 
OVERVIEW 
The polyethylene glycol (PEG) sealant utilized for arteriotomy site closure in the 
MynxGrip system was previously demonstrated to be safe and effective in the Matrix 
VSG study, a prospective, randomized, 500-patient proof of concept trial at 13 US 
centers. Furthermore, the pivotal trial demonstrated absence of major complications 
requiring surgical repair, low minor complication rates without need for additional 
intervention or hospitalization, rapid time to hemostasis regardless of ACT levels or anti-
coagulant use, and high device success rates (4).  
 
MynxGrip is currently an FDA approved VCD for arterial use, with a venous indication 
currently in review by the FDA. No technique change is proposed for the venous study. 
Hence, this is primarily a safety study for the MynxGrip extravascular, water-soluble 
sealant vascular closure device for use in venous hemostasis.  
 
The study will be conducted entirely at the MedStar Washington Hospital Center. 
Following either diagnostic or interventional procedures where venous access was 
required (via the common femoral vein with insertion of either 5, 6, or 7F sheath), 
femoral vein hemostasis will be achieved with either manual compression or the 
MynxGrip VCD system. A total of 208 patients will be prospectively enrolled in this study 
and will be followed for 7 days post procedure for safety purposes. To assess the 
primary safety outcome of venous patency and lack of occurrence of DVT, clinical 
assessment will be performed by the study team vascular access assessment group 

The Safety and Efficacy of an Extravascular, 
Water-Soluble Sealant for Venous Access-site Closure 
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and when clinically indicated a duplex ultrasound will be performed on patients prior to 
discharge to evaluation the presence of venous thrombosis. Patients will have final 
post-procedure telephone follow-up at 7 days to assess clinical findings consistent with 
any vascular or bleeding complications.  
 
After enrollment, subjects will be randomized 1:1 to: 
 Treatment Group A: Subjects will have venous hemostasis achieved using the 
MynxGrip vascular closure system in the common femoral vein.  
 Treatment Group B: Subjects will have venous hemostasis achieved using 
manual compression over the common femoral vein.  
Subjects who meet all inclusion criteria and none of the exclusion criteria, who agree to 
participate in this clinical study, and who sign an informed consent will be enrolled. 
 
Statistial Analysis  
 
Sample Size Calculation: The statistical objective was to evaluate whether the 
MynxGrip device was as safe as manual compression for achiving venous hemostasis. 
The rare occurance of venous thrombosis following catheter placement was used as the 
primary safety endpoint for calculation, with rates reported to be 2.4%. Using the 
Blackwelder method with α of 0.05, assuming event rates of 2.4% 6 in both arms, and a 
δ of 5% for noninferiority, the minimum required sample size for the MynxGrip group is 
104 patients. A total of 208 patient will be included. Analyisis will be performed on an 
intention-to-treat basis. 
 
 
 

The Safety and Efficacy of an Extravascular, 
Water-Soluble Sealant for Venous Access-site Closure 
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References:  
 
1. 
McGee DC, Gould MK. Preventing complications of central venous catheterization. N 
Engl J Med. 2003;348:1123-1133. 
2. 
Tavris DR, Dey S, Albrecht-Gallauresi B, Brindis RG, Shaw R, Weintraub W, Mitchel K. 
Risk of local adverse events following cardiac catheterization by hemostasis device use - phase 
II. J Invasive Cardiol. 2005;17:644-650. 
3. 
Marso SP, Amin AP, House JA, Kennedy KF, Spertus JA, Rao SV, Cohen DJ, 
Messenger JC, Rumsfeld JS. Association between use of bleeding avoidance strategies and risk 
of periprocedural bleeding among patients undergoing percutaneous coronary intervention. 
Jama. 2010;303:2156-2164. 
4. 
Scheinert D, Sievert H, Turco MA, Schmidt A, Hauptmann KE, Mueller R, Dadourian D, 
Krankenberg H, Grube E. The safety and efficacy of an extravascular, water-soluble sealant for 
vascular closure: initial clinical results for Mynx. Catheter Cardiovasc Interv. 2007;70:627-633. 
5. 
Verma D. LN, Tandar A., et al. Venous access closure using extravascular closure 
device: a propensity score-matched analysis. Abstract. EuroPCR. 2013. 
6. 
Zahn R, Fromm E, Thoma S, Lotter R, Zander M, Wagner S, Seidl K, Senges J. Local 
venous thrombosis after cardiac catheterization. Angiology. 1997;48:1-7.