Mynx M5 One Hour Ambulation Study (Mynx)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01100476|
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : February 15, 2013
|Condition or disease||Intervention/treatment||Phase|
|Angiography||Device: Endovascular Diagnostic Procedures||Phase 4|
- Patients >18 yrs of age
- Patient underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath via the common femoral artery.
- Patient is able to ambulate (routinely walk 6 meters or 20 feet without assistance for any reason) as assessed by investigator.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-center, Post Market, Prospective, Consecutive, Single-arm Study Compared to Historical Control (Diagnostic Arm of the Mynx 6/7F Study)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
Device: Endovascular Diagnostic Procedures
- Safety & Tolerability [ Time Frame: 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.
- Device success [ Time Frame: 30 +/- 7days ]Assess device success, time to dischargeability, major and minor complications in all patients enrolled in the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100476
|United States, New Jersey|
|Our Lady of Lourdes Medical Center|
|Camden, New Jersey, United States, 08103|
|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|