Trial Outcomes & Findings for A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System (NCT NCT01271946)

NCT ID: NCT01271946

Last Updated: 2013-01-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 351 participants
• Primary outcome timeframe: Procedure through 30 days follow-up.
• Results posted on: 2013-01-31

Participant Flow

Enrollment commenced November 3, 2010 and concluded June 3, 2011. Patients who underwent routine diagnostic catheterization through 5 or 6F sheaths were enrolled in the study at 8 investigational sites in the US.

Patients were required to be able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.

Participant milestones

Measure	Intent to Treat (ITT) The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful.	Sheath Greater Than 6 French (F) Subjects in whom the procedural sheath was upsized to greater than 6F.
Overall Study STARTED	346	5
Overall Study COMPLETED	346	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

Baseline characteristics by cohort

Measure	Intent to Treat n=346 Participants	Sheath Greater Than 6F n=5 Participants	Total n=351 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	161 Participants n=5 Participants	4 Participants n=7 Participants	165 Participants n=5 Participants
Age, Categorical >=65 years	185 Participants n=5 Participants	1 Participants n=7 Participants	186 Participants n=5 Participants
Age Continuous	64.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	63.2 years STANDARD_DEVIATION 11.7 • n=7 Participants	64.3 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	2 Participants n=7 Participants	153 Participants n=5 Participants
Sex: Female, Male Male	195 Participants n=5 Participants	3 Participants n=7 Participants	198 Participants n=5 Participants
Region of Enrollment United States	346 participants n=5 Participants	5 participants n=7 Participants	351 participants n=5 Participants

PRIMARY outcome

Timeframe: Procedure through 30 days follow-up.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Procedure through 30 day follow-up.

Observation of any major access site-related complication (percentage of participants).

Outcome measures

Measure	Intent to Treat n=346 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=5 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Major Adverse Events Reported as Percentage of Participants With Adverse Events.	0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Procedure

Population: Intent to treat.

Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.

Outcome measures

Measure	Intent to Treat n=346 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=5 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Device Success	97 Percentage of participants	100 Percentage of participants

PRIMARY outcome

Timeframe: Procedure through 30 day follow-up.

Observation of any minor access site-related complications.

Outcome measures

Measure	Intent to Treat n=346 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=5 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Minor Adverse Events	4.0 Percentage of participants	0 Percentage of participants

PRIMARY outcome

Timeframe: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.

Population: Per protocol.

The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.

Outcome measures

Measure	Intent to Treat n=334 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=4 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Time to Hemostasis	4.8 Minutes Standard Deviation 3.7 • Interval 4.4 to 5.2	6.0 Minutes Standard Deviation 4.2

PRIMARY outcome

Timeframe: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.

Population: Per Protocol.

The time from sheath removal to the time when the subject was medically able to be discharged based solely on the assessment of the access site.

Outcome measures

Measure	Intent to Treat n=333 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=4 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Time to Discharge Eligibility	6.0 Hours Standard Deviation 7.6	10.7 Hours Standard Deviation 9.9

PRIMARY outcome

Timeframe: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.

Population: Per protocol.

The time from sheath removal to actual hospital discharge.

Outcome measures

Measure	Intent to Treat n=335 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=4 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Time to Actual Discharge	9.3 Hours Standard Deviation 22.1	12.8 Hours Standard Deviation 11.8

PRIMARY outcome

Timeframe: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.

Population: Per protocol.

Time to ambulation was recorded as the difference between the time the procedural sheath is removed from the femoral artery and the time when the subject stands and walks at least 20 feet without re-bleeding.

Outcome measures

Measure	Intent to Treat n=332 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=4 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Time to Ambulation	2.0 Hours Standard Deviation 2.1	1.8 Hours Standard Deviation 0.5

PRIMARY outcome

Timeframe: Post procedure

Population: Per protocol.

Successful bed elevation was defined as the ability to sit up at a 45 degree angle within 15 minutes (1-30 minutes window) following sheath removal and successful hemostasis, without re-bleeding. This outcome was evaluated in subjects in whom successful access with the Arstasis device was achieved. The outcome measurement is reported as percentage of subjects.

Outcome measures

Measure	Intent to Treat n=245 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F n=1 Participants Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Percentage of Participants With Bed Elevation Within 15 Minutes.	99.6 Percentage of participants	20 Percentage of participants

SECONDARY outcome

Timeframe: Hemostasis was evaluated immediately following procedural sheath removal.

Population: Per protocol-Diagnostic Cohort.

Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.

Outcome measures

Measure	Intent to Treat n=241 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Time to Hemostasis	4.0 Minutes Standard Deviation 2.5	—

SECONDARY outcome

Timeframe: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.

Population: Per Protocol-Diagnostic Cohort.

Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.

Outcome measures

Measure	Intent to Treat n=240 Participants Major access site-related complications observed in the intent-to-treat population.	Sheath Greater Than 6F Major access site-related complications observed in subjects treated with sheath size greater than 6F.
Time to Ambulation	1.5 Hours Standard Deviation 1.2	—

Adverse Events

Intent to Treat

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sheath Greater Than 6F

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

Debra Cogan, Director of Quality, Regulatory and Clinical

Arstasis

Phone: 650-261-8073

Email: dcogan@arstasis.com

Results disclosure agreements

• Principal investigator is a sponsor employee Prior to submission for publication or presentation, the Institution will provide the Sponsor with at least sixty (60) days for review of a manuscript. If requested in writing,The Institution and Principal Investigator will withhold such publication for up to an additional sixty (60) days to allow for filing of a patent application.
• Publication restrictions are in place

Restriction type: OTHER