Mynx M5 One Hour Ambulation Study

This study has been completed.
Sponsor:
Collaborator:
AccessClosure, Inc.
Information provided by (Responsible Party):
Vijayendra K. Verma, MD, Cardiovascular Associates of the Delaware Valley
ClinicalTrials.gov Identifier:
NCT01100476
First received: April 5, 2010
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Angiography
Device: Endovascular Diagnostic Procedures
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)

Further study details as provided by Cardiovascular Associates of the Delaware Valley:

Primary Outcome Measures:
  • Safety & Tolerability [ Time Frame: Enrollment approx for 4 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Device success [ Time Frame: 30 +/- 7days ] [ Designated as safety issue: Yes ]
    Assess device success, time to dischargeability, major and minor complications in all patients enrolled in the study


Enrollment: 200
Study Start Date: March 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular Diagnostic Procedures
    Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
    Other Name: Angiography
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100476

Locations
United States, New Jersey
Our Lady of Lourdes Medical Center
Camden, New Jersey, United States, 08103
Sponsors and Collaborators
Cardiovascular Associates of the Delaware Valley
AccessClosure, Inc.
Investigators
Principal Investigator: Vijay K Verma, MD Cardiovascular Associates of the Delaware Valley
Study Director: Mary F Kinder, RN, BSN Cardiovascular Associates of the Delaware Valley
  More Information

No publications provided

Responsible Party: Vijayendra K. Verma, MD, Principal Investigator, Cardiovascular Associates of the Delaware Valley
ClinicalTrials.gov Identifier: NCT01100476     History of Changes
Other Study ID Numbers: 2010 - M5
Study First Received: April 5, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cardiovascular Associates of the Delaware Valley:
Closure Device
endovascular procedures
sealing femoral arterial access
Mynx M5

ClinicalTrials.gov processed this record on August 26, 2014