Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery IntroducerRECITALNCT01271946

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

A study testing Diagnostic catheterization procedure in people with Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer, run by Arstasis, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
What is being tested?: Diagnostic catheterization procedure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 351 participants
Where: 8 sitesUnited States
Study dates: Nov 2010to May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is between 18 and 85 years of age.
Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.

Who cannot join

Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
Patient has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mmHg diastolic).
Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count <100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin< 10 g/dL, or Hct<30%).
Patient has a compromised femoral artery access site.

Show all 13Show fewer

Patient procedure requires an introducer sheath size of> 6F.
Patient has had prior vascular surgery or vascular grafts at the femoral artery access site.
Patient presents with hemodynamic instability or is in need of emergent surgery.
Patient has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days of the current procedure.
Patient has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of< 30 dys or for other reasons has a life expectancy of less than 1 yaer.
Patient is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
Pregnant or lactating patients.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

The Cooper Health System
Camden, New Jersey, 08103
Mercy Hospital Fairfield
Fairfield, Ohio, 45014
Volunteer Research Group, LLC
Knoxville, Tennessee, 37920
P&S Surgical Hospital
Monroe, Louisiana, 71201
Cardiovascular Institute of the South-Opelousas
Opelousas, Louisiana, 70570
The Cardiovascular Center
Parker, Arizona, 85344
Sequoia Hospital
Redwood City, California, 94062
Willis-Knighton Hospital
Shreveport, Louisiana, 71103

Other trials in United States

About this study

The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.

Conditions: Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Being tested: Diagnostic catheterization procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diagnostic catheterization procedureDevice
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.

Study groups in NCT01271946
Study group	Role	What they receive
Diagnostic Procedure	Other	Not described Receives: Device: Diagnostic catheterization procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Measured: Procedure through 30 days follow-up.
Major Adverse Events Reported as Percentage of Participants With Adverse Events.
Observation of any major access site-related complication (percentage of participants).
Measured: Procedure through 30 day follow-up.
Device Success
Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.
Measured: Procedure
Minor Adverse Events
Observation of any minor access site-related complications.
Measured: Procedure through 30 day follow-up.
Time to Hemostasis
The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
Measured: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
Time to Discharge Eligibility
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.
Measured: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
Time to Actual Discharge
The time from sheath removal to actual hospital discharge.
Measured: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
Time to Ambulation
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.
Measured: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
Percentage of Participants With Bed Elevation Within 15 Minutes.
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.
Measured: Post procedure

Secondary outcomes (2)

Time to Hemostasis
Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.
Measured: Hemostasis was evaluated immediately following procedural sheath removal.
Time to Ambulation
Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.
Measured: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2011

First posted7 Jan 2011 (estimated)
Study startNov 2010
Primary completionMay 2011
Study completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery IntroducerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01271946
Sponsor's protocol ID: RC-03133
Acronym: RECITAL
Status last verified: Jan 2013
First submitted: 5 Jan 2011
Last updated: 31 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Turi ZG, Wortham DC, Sampognaro GC, Kresock FD, Held JS, Smith RD, Veerina KK, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial. J Invasive Cardiol. 2013 Jan;25(1):13-8.
PubMed 23293169

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System
ClinicalTrials.gov ID: NCT01271946
Acronym / sponsor ID: RECITAL / RC-03133
Conditions: Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Study type: Interventional
Recruitment status: Completed
Enrolment: 351 participants (actual)
Lead sponsor: Arstasis, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: May 2011 (actual)
Study completion: May 2011 (actual)
First posted: 7 Jan 2011 (estimated)
Results: Posted 17 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic Procedure	Other	Device: Diagnostic catheterization procedure

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patient is between 18 and 85 years of age.
Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.

Key exclusion criteria (13 listed)

Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
Patient has systemic hypertension unresponsive to treatment (>180mmHg systolic and >110mmHg diastolic).
Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count <100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin< 10 g/dL, or Hct<30%).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diagnostic catheterization procedureIntervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.	Device	Diagnostic Procedure

Primary outcome

Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Time frame: Procedure through 30 days follow-up.
Major Adverse Events Reported as Percentage of Participants With Adverse Events.
Time frame: Procedure through 30 day follow-up.
Observation of any major access site-related complication (percentage of participants).
Device Success
Time frame: Procedure
Achievement of femoral artery access using the Arstasis Access System followed by placement of the procedural sheath in the femoral artery.
Minor Adverse Events
Time frame: Procedure through 30 day follow-up.
Observation of any minor access site-related complications.
Time to Hemostasis
Time frame: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
The difference between the time the procedural sheath was removed from the femoral artery and the time when hemostasis was observed.
Time to Discharge Eligibility
Time frame: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
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.
Time to Actual Discharge
Time frame: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
The time from sheath removal to actual hospital discharge.
Time to Ambulation
Time frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
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.
Percentage of Participants With Bed Elevation Within 15 Minutes.
Time frame: Post procedure
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.

2 secondary outcomes

Time to Hemostasis
Time frame: Hemostasis was evaluated immediately following procedural sheath removal.
Time to Ambulation
Time frame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.

Results and safety

Results posted to the registry on 17 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intent to Treat (ITT)	346	346
Sheath Greater Than 6 French (F)	5	5

Primary outcome: Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.

Time frame: Procedure through 30 days follow-up.

The sponsor has not posted figures for this outcome.

Primary outcome: Major Adverse Events Reported as Percentage of Participants With Adverse Events.

Time frame: Procedure through 30 day follow-up.. Number. Unit: Percentage of participants

Measure	Intent to Treat n = 346	Sheath Greater Than 6F n = 5
Value	0	0

Primary outcome: Device Success

Time frame: Procedure. Number. Unit: Percentage of participants

Measure	Intent to Treat n = 346	Sheath Greater Than 6F n = 5
Value	97	100

Population analysed: Intent to treat.

Primary outcome: Minor Adverse Events

Time frame: Procedure through 30 day follow-up.. Number. Unit: Percentage of participants

Measure	Group 1 n = 346	Sheath Greater Than 6F n = 5
Value	4.0	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Procedure through 30 day post procedure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intent to Treat	0 of 346 (0%)	0 of 346 (0%)	Not reported
Sheath Greater Than 6F	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23293169Turi ZG, Wortham DC, Sampognaro GC, Kresock FD, Held JS, Smith RD, Veerina KK, Hinohara T, Kaki A. Use of a novel access technology for femoral artery catheterization: results of the RECITAL trial. J Invasive Cardiol. 2013 Jan;25(1):13-8.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zoltan Turi, MD principal investigator

Cooper Norcross Health

John Held, MD principal investigator

Mercy Hospital Fairfield

Frank Kresock, MD principal investigator

The Cardiovascular Center

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic catheterization procedure in people with Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer, run by Arstasis, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events. (time frame: Procedure through 30 days follow-up.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01271946, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.