Mynx M5 One Hour Ambulation Study

NCT01100476 | Completed Phase 4 DMC

• 1 other identifier: 2010 - M5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Angiography

Keywords

Closure Device; endovascular procedures; sealing femoral arterial access; Mynx M5

Outcome Measures

Primary Outcomes (1)

• Safety & Tolerability

  To assess safety and tolerability of participants ambulating within one hour of placement of the Mynx M5 Closure Device. Participants will be assessed for adverse event occurrence for 30 +/-7 days.

  Enrollment approx for 4 months

Secondary Outcomes (1)

• Device success

  30 +/- 7days

Interventions

Endovascular Diagnostic Procedures DEVICE

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

Also known as: Angiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiovascular Associates of the Delaware Valley: lead
• AccessClosure, Inc.: collaborator

Study Sites (1)

Our Lady of Lourdes Medical Center

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Interventions

Angiography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular

Study Officials

• Vijay K Verma, MD

  Cardiovascular Associates of the Delaware Valley

  PRINCIPAL INVESTIGATOR

• Mary F Kinder, RN, BSN

  Cardiovascular Associates of the Delaware Valley

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 9, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)