MOVE - Mobilization and Outcomes After VEnous Closure - A Prospective Registry of Real-World Outcomes/Usage/Evidence for the MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F

NCT07246902 RECRUITING

The primary objective of this post-market registry is to collect real-world outcomes and evaluate usage practice of MYNX CONTROL™ VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F in sealing femoral venous access sites in patients who have undergone endovascular procedures in a real-world setting.

Details

Lead sponsor	Cordis US Corp.
Status	RECRUITING
Enrolment	300
Start date	2025-11-24
Completion	2026-08

Conditions

• Venous Vascular Closure
• Electrophysiology Study

Interventions

• MYNX CONTROLTM VENOUS Vascular Closure Device

Primary outcomes

• Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications — From time of index procedure through end of following day (within 48 hours)
  Rate of patients who successfully received a study device at all access sites and had SDD without subsequent hospitalization/intervention for access-site complications either same day post-discharge or the next day
• Rate of access-site complications — From time of study device introduction at first access site through 14 days post-procedure
  Rate of access-site complications, assessed per standard of care, through 14 days post-procedure, including: * Access Site-Related Hematoma \> 6 cm documented by ultrasound * Local Access Site Infection confirmed by culture and sensitivity, treated with intramuscular or oral antibiotics * Allergic Reaction * Access site-related bleeding requiring transfusion, surgical intervention, or rehospitalization * Pulmonary embolism requiring surgical or endovascular intervention and/or resulting in death, to be confirmed by CT pulmonary angiography, lung ventilation/perfusion scan (VQ scan), or autopsy * Ipsilateral deep vein thrombosis, documented by ultrasound

Countries

United States