Mynx M5 One Hour Ambulation Study

Angiography Clinical Trial

— Mynx  

Official title:

Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100476
• Other study ID #: 2010 - M5
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2010
• Last updated: February 12, 2013
• Start date: March 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2013
• Source: Cardiovascular Associates of the Delaware Valley
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angiography

Intervention

Device:
• Endovascular Diagnostic Procedures
Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery

Locations

Country	Name	City	State
United States	Our Lady of Lourdes Medical Center	Camden	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Cardiovascular Associates of the Delaware Valley	AccessClosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Device success	Assess device success, time to dischargeability, major and minor complications in all patients enrolled in the study	30 +/- 7days	Yes