Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| NAMSA | OTHER |
Not provided
Not provided
Not provided
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.
The study is a single-arm, prospective, multi-center, observational, real-world registry of venous access site closures utilizing MYNX CONTROL™ VENOUS VCD 6F-12F following endovascular procedures. The study will enroll approximately 300 subjects in approximately 15 study sites in the United States.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCV VCD Treatment | Subjects who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYNX CONTROLTM VENOUS Vascular Closure Device | Device | The MYNX CONTROLTM VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing 6F to 12F procedural sheaths, with single or multiple access sites in one or both limbs. MCV VCD is designed to achieve femoral vein hemostasis via delivery of the GRIP TECHNOLOGY™ sealant (an extravascular, water-soluble synthetic hydrogel), using a balloon catheter in conjunction with a standard procedural sheath. The sealant is made of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the venotomy and is resorbed by the body within 30 days. The MCV VCD is supplied with a 10ml locking syringe used for balloon inflation and deflation. The catheter shaft has a silicone lubricant to facilitate insertion and withdrawal into compatible sheaths. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications | 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 | From time of index procedure through end of following day (within 48 hours) |
| Rate of access-site complications | Rate of access-site complications, assessed per standard of care, through 14 days post-procedure, including:
| From time of study device introduction at first access site through 14 days post-procedure |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Time to Ambulation | Defined as elapsed time (in hours) between removal of the final MCV VCD and when subject stands and walks 20 feet without evidence of rebleeding from any femoral venous access site. | From end of index procedure until time before hospital discharge (usually within ~24 hours of procedure) |
| Time to Discharge |
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
The study includes patients who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Nathan | Contact | 908-528-3931 | rajesh.nathan@cordis.com | |
| Jennifer Lee | Contact | 559-307-7753 | jennifer.lee02@cordis.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Denver Cardiology | Recruiting | Littleton | Colorado | 80210 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Defined as the elapsed time (in minutes) between removal of the final MCV VCD and when the subject is discharged from the hospital, as recorded on the discharge order. |
| From end of index procedure until time of hospital discharge (usually within ~24 hours of procedure) |
| Time to Hemostasis | Defined as elapsed time (in minutes) between removal of each MCV VCD and first observed and confirmed venous hemostasis (per access site analysis). | From time of index procedure until time before hospital discharge (usually within ~24 hours of procedure) |
| SDD sustained MCV VCD success | Defined as the proportion of subjects who did not require hospital intervention within 14 days post-procedure due to access site-related complications | From end of index procedure through 14 days post-procedure |
| Device success evaluated at the end of the procedure | Defined as the ability to deploy the delivery system and deliver the PEG component to achieve hemostasis at each access site | End of index procedure |
| Procedural Success | Defined as the attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 14 days | From end of index procedure through 14 days post-procedure |
| Procedural Time | Defined as time of first sheath insertion until the time of removal of final MCV VCD. | Index procedure |
| Recovery room time | Defined as elapsed time (in minutes) between when the subject is transferred to recovery and when the subject is discharged from the hospital, as recorded on the discharge order. | From time of transfer to recovery room post-discharge to time of discharge (usually within ~24 hours of procedure) |
| Analysis of Cost Effectiveness - Comprehensive summary of clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes | An analysis of cost effectiveness will be performed based on a summary of key clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes | From start time of index procedure through 14 days post-procedure |
| Incidence of urinary catheter usage | Number/rate of patients with urinary catheters used during the procedure | From start time of index procedure through end time of index procedure |
| Incidence of protamine usage | Incidence of protamine usage during the procedure | From start time of index procedure through end time of index procedure |
| Medication Usage | Rate of patients who are administered anti-platelet, anti-coagulant, anti-thrombotic, local anesthetic, protamine or pain medication | From pre-procedure though study exit/follow-up visit (14 +/- 7 days post-procedure) |
| KC Heart and Rhythm Institute | Recruiting | Overland Park | Kansas | 66211 | United States |
|
| North Carolina Heart & Vascular Research, LLC | Recruiting | Raleigh | North Carolina | 27607 | United States |
|