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

April 5, 2010
February 12, 2013
March 2010
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01100476 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Mynx M5 One Hour Ambulation Study
Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)

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

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.
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Angiography
Device: Endovascular Diagnostic Procedures
Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
Other Name: Angiography
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01100476
2010 - M5
Yes
Vijayendra K. Verma, MD, Cardiovascular Associates of the Delaware Valley
Cardiovascular Associates of the Delaware Valley
AccessClosure, Inc.
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
Cardiovascular Associates of the Delaware Valley
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP