Trial Outcomes & Findings for The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure (NCT NCT02438475)

Last Updated: 2020-11-18

Results Overview

i. Clinical: Physical exam findings consistent with venous thrombotic/thromboembolic related complication: * Redness or swelling at the venous puncture site * Increased lower extremity edema * Calf pain * New onset or worsening shortness of breath * New onset of pleuritic chest pain ii. and if clinically indicated, imaging: venous Doppler ultrasound assessment of obstructive or non-obstructive deep vein thrombosis (DVT)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

208 participants

Primary outcome timeframe

Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Results posted on

2020-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Mynx Vascular Closure System Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein 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.	Manual Compression Where patients will have venous hemostasis attempted to be achieved using manual compression alone Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes
Overall Study STARTED	104	104
Overall Study COMPLETED	102	104
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mynx Vascular Closure System n=104 Participants Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein 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.	Manual Compression n=104 Participants Where patients will have venous hemostasis attempted to be achieved using manual compression alone Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes	Total n=208 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	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	82 Participants n=5 Participants	78 Participants n=7 Participants	160 Participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	48 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	56 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	20 Participants n=5 Participants	32 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	69 Participants n=7 Participants	152 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	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants	104 participants n=7 Participants	208 participants n=5 Participants

PRIMARY outcome

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Outcome measures

Outcome measures
Measure	Mynx Vascular Closure System n=103 Participants Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein 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.	Manual Compression n=104 Participants Where patients will have venous hemostasis attempted to be achieved using manual compression alone Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes
Assessment of Venous Thrombosis	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

i. Damage to the vessel requiring surgical repair ii. Access site bleeding requiring the need for transfusion iii. Nerve injury at access site iv. Generalized infection (septicemia with typical signs, symptoms and positive blood cultures shortly after the index procedure, and requiring treatment with intravenous (IV) antibiotics)Pseudo-aneurysms requiring invasive treatment

Outcome measures

Outcome measures
Measure	Mynx Vascular Closure System n=103 Participants Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein 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.	Manual Compression n=104 Participants Where patients will have venous hemostasis attempted to be achieved using manual compression alone Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes
Bleeding or Vascular Related Complications	0 Participants	0 Participants

PRIMARY outcome

Timeframe: intraoperative

Device failure is defined as either the inability to deploy the device or device deployment with inadequate hemostasis requiring conversion to immediate manual pressure, or the eventual need for alternative methods to obtain hemostasis.

Outcome measures

Outcome measures
Measure	Mynx Vascular Closure System n=103 Participants Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein 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.	Manual Compression n=104 Participants Where patients will have venous hemostasis attempted to be achieved using manual compression alone Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes
Device/Procedure Failure	0 Participants	0 Participants

Adverse Events

Mynx Vascular Closure System

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Manual Compression

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mynx Vascular Closure System n=104 participants at risk Where subjects will have venous hemostasis attempted to be achieved using the Mynx Vascular Closure system alone Mynx Vascular Closure System: MynxGrip is being used to seal femoral vein 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.	Manual Compression n=104 participants at risk Where patients will have venous hemostasis attempted to be achieved using manual compression alone Manual Compression: manual pressure applied to your groin for approximately 5-10 minutes
Blood and lymphatic system disorders Access site thigh change >2 cm	6.7% 7/104 • Number of events 7 • procedure through hospital discharge	14.4% 15/104 • Number of events 15 • procedure through hospital discharge

Additional Information

Megan Rowland

Medstar Health Research Institute

Phone: 202-877-2959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place