Trial Outcomes & Findings for Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device (NCT NCT03923387)

Last Updated: 2026-07-29

Results Overview

The time to hemostasis is defined as the time from the sheath removal to the time to achieving hemostasis for the subject. The "hemostasis" here refers to that at the puncture site, there is no pulsating bleeding, nor expansionary/progressive hematoma.

Recruitment status

COMPLETED

Study phase

Target enrollment

306 participants

Primary outcome timeframe

Post procedure (time from the sheath removal to the time to achieving hemostasis)

Results posted on

2026-07-29

Participant Flow

Study enrollment began with first patient on 24-Apr-2019 and ended with last patient on 21-Sep-2020.

Participant milestones

Participant milestones
Measure	MynxGrip MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Overall Study STARTED	204	102
Overall Study COMPLETED	187	92
Overall Study NOT COMPLETED	17	10

Reasons for withdrawal

Reasons for withdrawal
Measure	MynxGrip MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Overall Study Adverse Event	2	1
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	14	8
Overall Study Physician Decision	1	0

Baseline Characteristics

Study to Evaluate the Safety and Effectiveness of MynxGrip Vascular Closure Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MynxGrip n=203 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=101 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery	Total n=304 Participants Total of all reporting groups
Age, Continuous	59.8 Years STANDARD_DEVIATION 10.83 • n=9 Participants	59.7 Years STANDARD_DEVIATION 10.60 • n=27 Participants	59.8 Years STANDARD_DEVIATION 10.74 • n=267 Participants
Sex: Female, Male Female	130 Participants n=9 Participants	69 Participants n=27 Participants	199 Participants n=267 Participants
Sex: Female, Male Male	73 Participants n=9 Participants	32 Participants n=27 Participants	105 Participants n=267 Participants
Race/Ethnicity, Customized Han	191 Participants n=9 Participants	97 Participants n=27 Participants	288 Participants n=267 Participants
Race/Ethnicity, Customized Other	12 Participants n=9 Participants	4 Participants n=27 Participants	16 Participants n=267 Participants
Height	1.661 m STANDARD_DEVIATION 0.0803 • n=9 Participants	1.661 m STANDARD_DEVIATION 0.0741 • n=27 Participants	1.661 m STANDARD_DEVIATION 0.0781 • n=267 Participants
Weight	69.09 Kg STANDARD_DEVIATION 10.669 • n=9 Participants	70.14 Kg STANDARD_DEVIATION 10.383 • n=27 Participants	69.44 Kg STANDARD_DEVIATION 10.569 • n=267 Participants
BMI	24.98 Kg/m^2 STANDARD_DEVIATION 2.950 • n=9 Participants	25.38 Kg/m^2 STANDARD_DEVIATION 3.092 • n=27 Participants	25.12 Kg/m^2 STANDARD_DEVIATION 2.998 • n=267 Participants

PRIMARY outcome

Timeframe: Post procedure (time from the sheath removal to the time to achieving hemostasis)

Population: The data represented here is the per-protocol population set, which includes all subjects from the full analysis set without major protocol deviation event affecting the effectiveness evaluation.

Outcome measures

Outcome measures
Measure	MynxGrip n=197 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=97 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Primary Effectiveness Endpoint: Time to Hemostasis	4.8 Min Standard Deviation 12.10	19.8 Min Standard Deviation 25.37

PRIMARY outcome

Timeframe: Through 30 days post procedure

Population: The data represented here is the safety analysis set, which includes all subjects who were randomized into groups, received treatment, and have safety data after treatment.

Defined as major complications during procedure, at discharge, and 30 days post procedure: vascular injury or vascular repair required; Permanent access site-related nerve injury; Access site-related nerve injury requiring a surgery; Access site-related bleeding requiring transfusion; New ipsilateral lower extremity ischemia discovered, which requires invasive/noninvasive intervention; Local access site-related infection combined with other indicators, which requires intervention; Classic signs/symptoms occurred in a short time after receiving the specified hemostasis procedures and generalized infection with positive blood culture, sepsis, which requiring intervention; Inflammatory reaction, including the local reaction and discharge of pus, which requires intervention

Outcome measures

Outcome measures
Measure	MynxGrip n=204 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=101 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Primary Safety Endpoint: Major Complication Rate	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Post procedure

Population: The data represented here is the full analysis set, which includes with major protocol deviation event affecting the effectiveness evaluation.

Defined as the time (in minutes) from sheath removal to when the patient can walk about at least 6 meters (or 20 steps). Compare whether there are differences in the time to ambulation (for patients receiving a diagnostic procedure) between the two groups.

Outcome measures

Outcome measures
Measure	MynxGrip n=195 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=97 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Secondary Effectiveness Endpoint: Time to Ambulation	657.0 Min Standard Deviation 641.64	1306.3 Min Standard Deviation 269.84

SECONDARY outcome

Timeframe: Index procedure through discharge

Population: The data represented here is the full analysis set, which includes with major protocol deviation event affecting the effectiveness evaluation.

Defined as the time (in minutes) from sheath removal to patient discharge (for patients receiving a diagnostic procedure). Compare whether there are differences in the length of stay (for patients receiving a diagnostic procedure) between the two groups.

Outcome measures

Outcome measures
Measure	MynxGrip n=80 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=46 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Secondary Effectiveness Endpoint: Length of Hospital Stay	3104.9 Min Standard Deviation 2356.68	2721.1 Min Standard Deviation 1676.36

SECONDARY outcome

Timeframe: Index procedure

Population: The data represented here is the full analysis set, which includes with major protocol deviation event affecting the effectiveness evaluation.

Defined as successfully achieving hemostasis using the investigational medical device or control methods (including but are not limited to the assigned therapeutic method and other supplementary means) with absence of major complications. Compare whether there are differences in the procedure success rate (for patients receiving a diagnostic procedure) between the two groups.

Outcome measures

Outcome measures
Measure	MynxGrip n=203 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=101 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Secondary Effectiveness Endpoint: Procedure Success Rate	202 Participants	101 Participants

SECONDARY outcome

Timeframe: Intraoperatively

Population: The data represented here is the full analysis set, which includes with major protocol deviation event affecting the effectiveness evaluation.

Defined as the device being successfully removed in accordance with the standard operating procedure

Outcome measures

Outcome measures
Measure	MynxGrip n=203 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Secondary Effectiveness Endpoint: Device Success Rate	194 Participants	—

SECONDARY outcome

Timeframe: Through 30 days post procedure

Population: The data represented here is the safety analysis set, which includes all subjects who were randomized into groups, received treatment, and have safety data after treatment.

Compare whether there are differences in rates of minor complications between the two groups

Outcome measures

Outcome measures
Measure	MynxGrip n=204 Participants MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=101 Participants Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Secondary Safety Endpoint: Minor Complication Rate	3 percentage of participants	1 percentage of participants

Adverse Events

MynxGrip

Serious events: 10 serious events

Other events: 65 other events

Deaths: 0 deaths

Manual Compression

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MynxGrip n=204 participants at risk MynxGrip, a vascular closure device indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. MynxGrip: Vascular Closure	Manual Compression n=101 participants at risk Manual compression hemostasis Manual compression: Manual compression is a commonly used method to achieve hemostasis of femoral artery
Nervous system disorders Left Intracranial Hemorrhage	0.00% 0/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.99% 1/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Hepatobiliary disorders Cholecystitis	0.00% 0/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.99% 1/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Gastrointestinal disorders Retroperitoneal Hematoma	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Cardiac disorders Heart Disease	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Cancer	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Blood and lymphatic system disorders Splenic Infarction	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Nervous system disorders Aneurysm	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Nervous system disorders Moyamoya Disease	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal Fibroangioma	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Renal and urinary disorders Renal Artery Dissection Aneurysm	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Nervous system disorders Vertebral Artery Stenosis	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.
Nervous system disorders Intraventricular Hemorrhage	0.49% 1/204 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.	0.00% 0/101 • 30 days follow-up The protocol definition, "An AE is defined as any untoward medical occurrence in the process of clinical trial, regardless of its relationship to the investigational medical device" differs from the clinicaltrials.gov definition in that the latter states, "whether or not considered related to the participant's participation in the research." Otherwise, the definitions are similar as they relate to any untoward event that occurs during the subject's participation in the clinical trial.

Other adverse events

Additional Information

Jennifer Lee

Cordis US Corp

Phone: +1 669 699 6851

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place