The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure

NCT02438475 | Completed Phase 4 Results FDA Device

• 1 other identifier: Vascular Closure Venous Mynx
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiac Diagnostic Procedure; Cardiac Interventional Procedure; Femoral Access Site Closure

Outcome Measures

Primary Outcomes (3)

• Assessment of Venous Thrombosis

  i. Clinical: Physical exam findings consistent with venous thrombotic/thromboembolic related complication: * Redness or swelling at the venous puncture site * Increased lower extremity edema * Calf pain * New onset or worsening shortness of breath * 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)

  Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

• 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

  Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

• 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.

  intraoperative

Study Arms (2)

Mynx Vascular Closure System

ACTIVE COMPARATOR

Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone

Device: Mynx Vascular Closure System

Manual Compression

OTHER

Where patients will have venous hemostasis attempted to be achieved using manual compression alone

Other: Manual Compression

Interventions

Mynx Vascular Closure System DEVICE

MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

Also known as: MynxGrip Vascular Closure Device

Mynx Vascular Closure System

Manual Compression OTHER

manual pressure applied to your groin for approximately 5-10 minutes

Manual Compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient has a history of a bleeding disorder
• Previous history of venous thrombosis or thromboembolism
• Patient is pregnant or lactating
• Patient has a known severe allergy to contrast medium
• Patient has a known allergy to PEG
• \. Patient is known 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 in the target vein 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Cardinal Health: collaborator

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MedStar Southern Maryland Hospital

Clinton, Maryland, 20735, United States

Location

Related Publications (5)

• McGee DC, Gould MK. Preventing complications of central venous catheterization. N Engl J Med. 2003 Mar 20;348(12):1123-33. doi: 10.1056/NEJMra011883. No abstract available.

  PMID: 12646670 RESULT

• 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 Dec;17(12):644-50.

  PMID: 16327045 RESULT

• Marso SP, Amin AP, House JA, Kennedy KF, Spertus JA, Rao SV, Cohen DJ, Messenger JC, Rumsfeld JS; National Cardiovascular Data Registry. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA. 2010 Jun 2;303(21):2156-64. doi: 10.1001/jama.2010.708.

  PMID: 20516416 RESULT

• 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 Nov 1;70(5):627-33. doi: 10.1002/ccd.21353.

  PMID: 17960627 RESULT

• Zahn R, Fromm E, Thoma S, Lotter R, Zander M, Wagner S, Seidl K, Senges J. Local venous thrombosis after cardiac catheterization. Angiology. 1997 Jan;48(1):1-7. doi: 10.1177/000331979704800101.

  PMID: 8995337 RESULT

Results Point of Contact

• Title: Megan Rowland
• Organization: Medstar Health Research Institute

megan.e.rowland@medstar.net

202-877-2959

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 8, 2015
• Study Start: June 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 18, 2020
• Results First Posted: November 18, 2020

Record last verified: 2020-10

Locations

US (2)