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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arstasis, Inc.
ClinicalTrials.gov Identifier:
NCT01271946
First received: January 5, 2011
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Device: Diagnostic catheterization procedure

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

Further study details as provided by Arstasis, Inc.:

Primary Outcome Measures:
  • Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events. [ Time Frame: Procedure through 30 days follow-up. ] [ Designated as safety issue: Yes ]
  • Major Adverse Events Reported as Percentage of Participants With Adverse Events. [ Time Frame: Procedure through 30 day follow-up. ] [ Designated as safety issue: Yes ]
    Observation of any major access site-related complication (percentage of participants).

  • Device Success [ Time Frame: Procedure ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Hemostasis [ Time Frame: Hemostasis was evaluated immediately following procedural sheath removal. ] [ Designated as safety issue: No ]
    Time to hemostasis for the diagnostic cohort, compared to published literature rates of 17 minutes for time to hemostasis for standard manual compression.

  • 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. ] [ Designated as safety issue: No ]
    Time to ambulation for the diagnostic cohort, compared to published literature rates of 4.75 hours for time to ambulation for standard manual compression.


Enrollment: 351
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diagnostic Procedure Device: Diagnostic catheterization procedure
Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271946

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

No publications provided by Arstasis, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Arstasis, Inc.
ClinicalTrials.gov Identifier: NCT01271946     History of Changes
Other Study ID Numbers: RC-03133
Study First Received: January 5, 2011
Results First Received: October 26, 2012
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014