Trial Outcomes & Findings for The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System (NCT NCT02136004)

NCT ID: NCT02136004

Last Updated: 2017-10-27

Results Overview

Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

220 participants

Primary outcome timeframe

procedural, usually within 15 minutes of enrollment

Results posted on

2017-10-27

Participant Flow

Participant milestones

Participant milestones
Measure	Closer VSS Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Overall Study STARTED	220
Overall Study COMPLETED	219
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Closer VSS - Diagnostic Cohort n=111 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases. Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.	Closer VSS - Interventional Cohort n=109 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases. Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.	Total n=220 Participants Total of all reporting groups
Age, Continuous	63.2 years STANDARD_DEVIATION 10.3 • n=5 Participants	64.7 years STANDARD_DEVIATION 8.7 • n=7 Participants	63.9 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	25 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	66 Participants n=5 Participants	84 Participants n=7 Participants	150 Participants n=5 Participants

PRIMARY outcome

Timeframe: procedural, usually within 15 minutes of enrollment

Population: All subjects enrolled

Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Time to Hemostasis	1.78 minutes Interval 0.74 to 2.82

PRIMARY outcome

Timeframe: Through 30 days +/- 7 days

Population: All subjects enrolled

Primary safety endpoint - rate of combined major access site closure-related complications

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Rate of Combined Major Access Site Closure-related Complications	0 complications

SECONDARY outcome

Timeframe: prior to hospital discharge, usually within 24 hours

Population: All subjects enrolled

Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Time to Ambulation	2.50 hours Interval 2.36 to 2.64

SECONDARY outcome

Timeframe: prior to hospital discharge, usually within 24 hours

Population: All subjects enrolled

Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Time to Discharge Eligibility	2.83 hours Interval 2.62 to 3.03

SECONDARY outcome

Timeframe: through hospital discharge, usually within 24 hours

Population: All subjects enrolled

Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Time to Hospital Discharge	13.12 hours Interval 10.93 to 15.32

SECONDARY outcome

Timeframe: procedural, usually within 15 minutes of enrollment

Population: All subjects enrolled

Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Device Success	216 Participants

SECONDARY outcome

Timeframe: through 30 +/- 7 days

Population: All subjects enrolled

Secondary safety endpoint - rate of combined minor access site closure-related complications

Outcome measures

Outcome measures
Measure	Closer VSS n=220 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Rate of Combined Minor Access Site Closure-related Complications	3 complications

SECONDARY outcome

Timeframe: through 30 days +/- 7 days

Population: All subjects enrolled.

Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days

Outcome measures

Outcome measures
Measure	Closer VSS n=219 Participants Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Procedure Success	219 Participants

Adverse Events

Closer VSS

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Closer VSS n=220 participants at risk Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Vascular disorders Serious device-related adverse events, excluding endpoint events	0.00% 0/220

Other adverse events

Other adverse events
Measure	Closer VSS n=220 participants at risk Rex Medical Closer Vascular Sealing System to close femoral arteriotomy Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
Vascular disorders Non-serious access site bleeding	5.5% 12/220 • Number of events 12

Additional Information

S. Chiu Wong, MD

Weill Cornell Medical College

Phone: 212-746-4644

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place