Trial Outcomes & Findings for Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device (NCT NCT00345631)

NCT ID: NCT00345631

Last Updated: 2012-06-01

Results Overview

Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 488 participants
• Primary outcome timeframe: From when the introducer sheath was removed to the time hemostasis was first observed
• Results posted on: 2012-06-01

Participant Flow

Participant milestones

Measure	Roll-In Roll-In patients were device training patients	Vascular Closure Device Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Overall Study STARTED	87	267	134
Overall Study COMPLETED	83	259	128
Overall Study NOT COMPLETED	4	8	6

Reasons for withdrawal

Measure	Roll-In Roll-In patients were device training patients	Vascular Closure Device Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Overall Study Withdrawal by Subject	1	0	1
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	3	7	4
Overall Study Other reasons	0	0	1

Baseline Characteristics

Safety and Effectiveness Study of the Ensure Medical Vascular Closure Device

Baseline characteristics by cohort

Measure	Roll-In n=87 Participants Roll-In patients were device training patients	Vascular Closure Device n=267 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=134 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)	Total n=488 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	144 Participants n=7 Participants	83 Participants n=5 Participants	274 Participants n=4 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	123 Participants n=7 Participants	51 Participants n=5 Participants	214 Participants n=4 Participants
Age Continuous	63.3 years STANDARD_DEVIATION 11.61 • n=5 Participants	63.3 years STANDARD_DEVIATION 11.13 • n=7 Participants	61.4 years STANDARD_DEVIATION 10.47 • n=5 Participants	62.8 years STANDARD_DEVIATION 11.05 • n=4 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	85 Participants n=7 Participants	51 Participants n=5 Participants	165 Participants n=4 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	182 Participants n=7 Participants	83 Participants n=5 Participants	323 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=5 Participants	260 Participants n=7 Participants	126 Participants n=5 Participants	470 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	23 Participants n=7 Participants	13 Participants n=5 Participants	46 Participants n=4 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	236 Participants n=7 Participants	114 Participants n=5 Participants	427 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	87 participants n=5 Participants	267 participants n=7 Participants	134 participants n=5 Participants	488 participants n=4 Participants

PRIMARY outcome

Timeframe: From when the introducer sheath was removed to the time hemostasis was first observed

Population: Intent to treat population (ITT) with non-missing time to hemostasis data. ITT population consists of all randomized (VCD and MC) patients where a femoral artery closure procedure is attempted post-randomization.

Time to hemostasis is defined as time (in minutes) from when the introducer sheath was removed to the time that hemostasis was first observed during post-procedure follow up. Hemostasis is defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma. Time to hemostasis is one of the two co-primary endpoints.

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=267 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=131 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Time to Hemostasis (TTH)	4.68 Minutes Standard Deviation 19.37	4.38 Minutes Standard Deviation 11.59	20.05 Minutes Standard Deviation 22.54

PRIMARY outcome

Timeframe: From when the introducer sheath was removed to 30 days post-procedure

Population: Intent to Treat (ITT)Population with non-missing time to ambulation data.

Time to ambulation is defined as the time from when the introducer sheath was removed to the time that ambulation was achieved. Ambulation is defined as patient standing and walking at least 20 feet without re-bleeding or significant oozing requiring manual compression. Time to ambulation is one of the two co-primary endpoints.

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=264 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=129 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Time to Ambulation (TTA)	1.98 Hours Standard Deviation 2.59	2.54 Hours Standard Deviation 5.02	6.24 Hours Standard Deviation 13.34

PRIMARY outcome

Timeframe: From post-procedure to 30 days follow up

Population: Intent to treat population

Vascular closure related major adverse events consist of any of the events below: Vascular repair or the need for repair; access site-related bleeding requiring transfusion; access site-related infection requiring intravenous/intramuscular antibiotics and/or extended hospitalization; any new ipsilateral lower extremity ischemia documented by symptoms, physical exam, and/or decreased or absent blood flow on lower extremity angiogram; surgery for access site-related nerve injury; and Permanent (> 30 days) access site-related nerve injury.

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=267 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=134 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Percentage of Patients Who Experience Any Vascular Closure Related Major Adverse Events During the 30 Days Post-procedure	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: From introducer sheath removal to hospital discharge, up to 284 hours

Population: Intent to treat population with non-missing time data

Time to Eligibility for Hospital Discharge is measured from the time of sheath removal to the time when the patient is eligible for discharge according to the judgment of the patient's physician.

Outcome measures

Measure	Roll-In n=85 Participants patients were device training patients	Vascular Closure Device n=257 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=128 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Time to Eligibility for Hospital Discharge	9.72 Hour Standard Deviation 14.15	12.57 Hour Standard Deviation 13.91	16.25 Hour Standard Deviation 27.49

SECONDARY outcome

Timeframe: From introducer sheath removal to patient discharge

Population: Intent to Treat population with non-missing time data

Time to hospital discharge is defined as from the time of sheath removal to the time of hospital discharge

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=264 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=133 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Time to Hospital Discharge	13.64 Hour Standard Deviation 18.54	16.77 Hour Standard Deviation 19.79	19.35 Hour Standard Deviation 29.23

SECONDARY outcome

Timeframe: From device inserted to introducer sheath removal

Population: Intent to Treat population with non-missing time data, excluding MC patients. Patients in the MC arm didn't deploy the device.

Time to device deployment is defined as from the time device inserted to the time sheath removed

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=260 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Time to Device Deployment, up to 5 Minutes	0.94 Hour Standard Deviation 1.13	1.01 Hour Standard Deviation 2.12	—

SECONDARY outcome

Timeframe: Within 5 minutes post-procedure

Population: Intent to treat population (ITT) excluding the Manual Compression (MC) patients since MC Patients didn't deploy the device.

Device Success is defined as the successful deployment of the plug, initial hemostasis time less or equal to 5 minutes, and removal of the intact delivery system.

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=267 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Percentage of Patients Who Achieved Device Success Within Five Minutes Post-procedure	95.4 Percentage of participants	89.1 Percentage of participants	—

SECONDARY outcome

Timeframe: From catheterization procedure to 30 day post-procedure follow up

Population: Intent to Treat Population

Procedure success is defined as initial hemostasis achieved by the assigned method Vascular Closure Device (VCD) or Manual compression (MC) with none of the primary safety endpoint's closure related major adverse events (MAE). Procedural success is assessed on day of catheterization procedure and at 30 days post-procedure.

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=267 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=134 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Percent of Patients Who Achieved Procedure Success During 30 Days Post-procedure	95.4 Percentage of participants	91.8 Percentage of participants	91.0 Percentage of participants

SECONDARY outcome

Timeframe: From end of vessel closure procedure to 30 days post-procedure

Population: Intent to treat population

Other known vascular closure related adverse events include: Rebleeding Following Initial Hemostasis; Access Site Hematoma >= 6cm; Access Site-Related Bleeding Requiring > 30 min for Hemostasis; Transient Access Site-Related Nerve Injury; Retroperitonea Bleeding; Decrease in Pedal Pulse

Outcome measures

Measure	Roll-In n=87 Participants patients were device training patients	Vascular Closure Device n=267 Participants Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=134 Participants Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Percentage of Patients Who Experienced Any Other Vascular Closure Related Adverse Events	10.3 Percentage of participants	8.99 Percentage of participants	4.48 Percentage of participants

Adverse Events

Roll-In

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Vascular Closure Device

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Manual Compression

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Roll-In n=87 participants at risk Roll-In patients were device training patients	Vascular Closure Device n=267 participants at risk Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.	Manual Compression n=134 participants at risk Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
Blood and lymphatic system disorders Rebleeding Following Initial Hemostasis	3.4% 3/87 • Number of events 3	5.2% 14/267 • Number of events 14	2.2% 3/134 • Number of events 3
Blood and lymphatic system disorders Access Site Hematoma >= 6cm	3.4% 3/87 • Number of events 3	2.2% 6/267 • Number of events 6	0.75% 1/134 • Number of events 1
Blood and lymphatic system disorders Access Site-Related Bleeding Requiring > 30 min for Hemostasis	1.1% 1/87 • Number of events 1	0.37% 1/267 • Number of events 1	0.75% 1/134 • Number of events 1
Nervous system disorders Transient Access Site-Related Nerve Injury	0.00% 0/87	0.37% 1/267 • Number of events 1	0.00% 0/134
Blood and lymphatic system disorders Retroperitoneal Bleeding	0.00% 0/87	0.75% 2/267 • Number of events 2	0.00% 0/134
Blood and lymphatic system disorders Eochymosis >= 6cm	1.1% 1/87 • Number of events 1	0.00% 0/267	0.75% 1/134 • Number of events 1
Blood and lymphatic system disorders Decrease in Pedal Pulse	1.1% 1/87 • Number of events 1	0.00% 0/267	0.00% 0/134

Additional Information

Hans-Peter Stoll, M.D.

Cordis Corporation, a Johnson&Johnson company

Phone: 908-541-4770

Email: hpstoll@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60