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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01100476

Acronym

Mynx

Enrollment

200

Registered

2010-04-09

Start date

2010-03-31

Completion date

2011-08-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiography

Keywords

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

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

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.

Interventions

DEVICEEndovascular Diagnostic Procedures

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety & Tolerability	Enrollment approx for 4 months	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026