Trial Outcomes & Findings for Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression (NCT NCT05554471)

Last Updated: 2025-04-24

Results Overview

Defined as the rate of CEC adjudicated combined major venous access site closure-related complications through 30 days post-procedure, attributed directly to VCD or Manual Compression without other likely cause.

Recruitment status

COMPLETED

Study phase

Target enrollment

352 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2025-04-24

Participant Flow

Study enrollment began on 30Aug2022, and enrollment ended on 22May2023.

352 subjects agreed to participate in the study following the completion of the informed consent process. Among 352 enrolled subjects, 44 were included as roll-in subjects, and 38 were screen failures. Both roll-in and screen-failed subjects were not assigned to either arm.

Participant milestones

Participant milestones
Measure	MYNX CONTROL™ VENOUS VCD Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Overall Study STARTED	177	93
Overall Study COMPLETED	173	90
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MYNX CONTROL™ VENOUS VCD Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Overall Study Physician Decision	2	1
Overall Study Lost to Follow-up	2	1
Overall Study Death	0	1

Baseline Characteristics

Evaluation of Safety and Efficacy of the Mynx Control Venous Vascular Closure Device 6F-12F vs Manual Compression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MYNX CONTROL™ Venous VCD n=177 Participants Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=93 Participants Patients received Manual Compression in sealing femoral venous access sites.The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Total n=270 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	61 Participants n=5 Participants	26 Participants n=7 Participants	87 Participants n=5 Participants
Age, Categorical >=65 years	116 Participants n=5 Participants	67 Participants n=7 Participants	183 Participants n=5 Participants
Age, Continuous	66.7 Years STANDARD_DEVIATION 11.62 • n=5 Participants	66.8 Years STANDARD_DEVIATION 10.63 • n=7 Participants	66.7 Years STANDARD_DEVIATION 11.27 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	32 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	61 Participants n=7 Participants	178 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	2 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	87 Participants n=7 Participants	245 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	167 Participants n=5 Participants	89 Participants n=7 Participants	256 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	177 participants n=5 Participants	93 participants n=7 Participants	270 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=229 limbs Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=119 limbs Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Primary Safety Endpoint: Major Complications of the Target Limb Access Site Within 30 Days	0 limbs	1 limbs

PRIMARY outcome

Timeframe: Post procedure

Population: Five (5) MYNX CONTROL VENOUS VCD subjects with missing data and Two (2) Manual Compression subjects with missing data.

Defined as time (in hours) between removal of the MYNX CONTROL™ Venous Vascular Closure Device 6F-12F device (device group) or of the final sheath (control group) and when subject stands and walks 20 feet without evidence of rebleeding from any femoral venous access site.

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=172 Participants Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=91 Participants Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Primary Effectiveness Endpoint: Time to Ambulation	2.6 hours Standard Deviation 1.03	5.1 hours Standard Deviation 4.35

PRIMARY outcome

Timeframe: Post procedure

Defined as time (in minutes) between removal of each MYNX CONTROL™ Venous Vascular Closure Device 6F-12F device (device group) or of each sheath (control group) and first observed and confirmed venous hemostasis (per access site analysis).

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=470 access sites Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=249 access sites Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Primary Effectiveness Endpoint: Time to Hemostasis	2.1 minutes Standard Deviation 1.79	11.4 minutes Standard Deviation 7.19

SECONDARY outcome

Timeframe: 30 days post procedure

Defined as the rate of CEC adjudicated combined minor venous access site closure-related complications through 30 days post-procedure, attributed directly to MYNX CONTROL™ Venous VCD or Manual Compression without other likely cause.

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=229 limbs Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=119 limbs Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Secondary Safety Endpoints: Minor Complications of the Target Limb Access Site Within 30 Days	0 limbs	6 limbs

SECONDARY outcome

Timeframe: Post Procedure

Population: There were 4 missing data in the MYNX CONTROL VENOUS VCD group and 2 missing data in the Manual Compression group

Defined as elapsed time (in hours) between removal of the final MYNX CONTROL™ Venous VCD or removal of the final sheath and when subject is eligible for discharge from the institution based on the assessment of the attending physician.

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=173 Participants Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=91 Participants Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Time to Discharge Eligibility	3.1 hours Standard Deviation 1.24	5.5 hours Standard Deviation 4.58

SECONDARY outcome

Timeframe: 30 days post procedure

Population: Six (6) MYNX CONTROL VENOUS VCD subjects with missing data and three (3) Manual Compression subjects with missing data.

Defined as attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 30 days.

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=171 Participants Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=90 Participants Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Procedural Success	171 Participants	89 Participants

SECONDARY outcome

Timeframe: During procedure

Defined as the ability to successfully deploy the MYNX CONTROL™ VENOUS VCD delivery system, deliver the polyethylene glycol hydrogel sealant, and achieve hemostasis.

Outcome measures

Outcome measures
Measure	MYNX CONTROL™ VENOUS VCD n=470 access sites Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Device Success	470 access sites	—

Adverse Events

MYNX CONTROL™ VENOUS VCD

Serious events: 10 serious events

Other events: 16 other events

Deaths: 0 deaths

Manual Compression

Serious events: 4 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	MYNX CONTROL™ VENOUS VCD n=175 participants at risk Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=92 participants at risk Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Injury, poisoning and procedural complications Procedural nausea	6.3% 11/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Vascular disorders Haematoma	2.9% 5/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	5.4% 5/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.

Additional Information

Jenny Jimenez

Cordis

Phone: +1 646 483-6846

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	MYNX CONTROL™ VENOUS VCD n=175 participants at risk Patients received MYNX CONTROL™ Venous Vascular Closure Device 6F-12F in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.	Manual Compression n=92 participants at risk Patients received Manual Compression in sealing femoral venous access sites. The patients have undergone endovascular procedures utilizing one or more procedural sheaths up to 12F.
Cardiac disorders Cardiac failure congestive	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Cardiac disorders Pericardial effusion	0.00% 0/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	1.1% 1/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Cardiac disorders Sinus bradycardia	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Gastrointestinal disorders Haematochezia	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
General disorders Chest pain	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
General disorders Systemic inflammatory response syndrome	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Infections and infestations Rhinovirus infection	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Nervous system disorders Cerebrovascular accident	0.00% 0/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	2.2% 2/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Nervous system disorders Psychogenic seizure	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Renal and urinary disorders Haematuria	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	1.1% 1/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Vascular disorders Arterial haemorrhage	0.00% 0/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	1.1% 1/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Vascular disorders Hypertension	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.
Vascular disorders Vascular compression	0.57% 1/175 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.	0.00% 0/92 • 30 days follow-up Two (2) MYNX CONTROL VENOUS VCD subjects and one (1) Manual Compression subject were terminated prior to the procedure and were missing data.