A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System (RECITAL)

January 23, 2013 updated by: Arstasis, Inc.
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
351

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Diagnostic Procedure
Device: Diagnostic catheterization procedure
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
Time Frame: Procedure through 30 days follow-up.
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).
Procedure through 30 day follow-up.
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.
Procedure
Minor Adverse Events
Time Frame: Procedure through 30 day follow-up.
Observation of any minor access site-related complications.
Procedure through 30 day follow-up.
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.
Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
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.
Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable 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.
Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
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.
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.
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.
Post procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to Hemostasis
Time Frame: Hemostasis was evaluated immediately following procedural sheath removal.
Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.
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.
Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.
Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Arstasis, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zoltan Turi, MD, The Cooper Health System
  • Principal Investigator: John Held, MD, Mercy Hospital Fairfield
  • Principal Investigator: Frank Kresock, MD, The Cardiovascular Center
  • Principal Investigator: Tom Hinohara, MD, Sequoia Hospital
  • Principal Investigator: Dale Wortham, MD, Volunteer Research Group, LLC
  • Principal Investigator: Greg Sampognaro, MD, P&S
  • Principal Investigator: Ray Smith, MD, Ark-La-Tex Cardiology/Willis-Knighton Hospital
  • Principal Investigator: Kalyan Veerina, MD, Cardiovascular Institute of the South-Opelousas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC-03133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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