Trial Outcomes & Findings for Patient Comfort With Vascular Closure (NCT NCT00998023)

NCT ID: NCT00998023

Last Updated: 2011-12-06

Results Overview

The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 64 participants
• Primary outcome timeframe: Immediately before vascular closure and immediately after vascular closure.
• Results posted on: 2011-12-06

Participant Flow

Participants were recruited from the clinical practice of the investigator between November 2009 and July 2010.

Participants who had any groin pain before placement of the closure device were excluded.

Participant milestones

Measure	Mynx VCD Mynx Vascular Closure Device	AngioSeal VCD AngioSeal Vascular Closure Device
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Comfort With Vascular Closure

Baseline characteristics by cohort

Measure	Mynx VCD n=32 Participants Mynx Vascular Closure Device	AngioSeal VCD n=32 Participants AngioSeal Vascular Closure Device	Total n=64 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	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	32 participants n=7 Participants	64 participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately before vascular closure and immediately after vascular closure.

Population: Per protocol

The Visual Analogue Scale measures the severity of pain on a continuous scale from 0 (no pain) to 10 (worst possible pain).

Outcome measures

Measure	Mynx VCD n=32 Participants Mynx Vascular Closure Device	AngioSeal VCD n=32 Participants AngioSeal Vascular Closure Device
Mean Score on the Visual Analogue Scale Before Closure	0.63 Scores on a Scale Standard Error 1.01	0.59 Scores on a Scale Standard Error 1.04
Mean Score on the Visual Analogue Scale After Closure	2.94 Scores on a Scale Standard Error 0.42	5.03 Scores on a Scale Standard Error 0.56

SECONDARY outcome

Timeframe: 1 Day

Population: Per protocol

Number of participants with permanent access site-related nerve injury, access-site related surgical/vascular repair, amputation related to access closure complication, access site-related bleeding/hematoma requiring transfusion, any new ipsilateral lower extremity ischemia requiring non-surgical intervention, local access site-related or generalized infection requiring prolonged hospitalization or re-hospitalization and treatment with IV antibiotics or inflammatory reaction that may include local signs and drainage, treated with re-hospitalization, IV antibiotics and/or surgical intervention

Outcome measures

Measure	Mynx VCD n=32 Participants Mynx Vascular Closure Device	AngioSeal VCD n=32 Participants AngioSeal Vascular Closure Device
Major Complications	0 Participants	0 Participants

Adverse Events

Mynx VCD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AngioSeal VCD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

J Mocco, M.D.

University of Florida

Phone: 352-273-9000

Email: jmocco@neurosurgery.ufl.edu

Results disclosure agreements

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