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

NCT01271946 | Completed Results

• 1 other identifier: RC-03133
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.

  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).

  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.

  Procedure

• Minor Adverse Events

  Observation of any minor access site-related complications.

  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.

  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.

  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.

  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.

  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.

  Post procedure

Secondary Outcomes (2)

• Time to Hemostasis

  Hemostasis was evaluated immediately following procedural sheath removal.

• Time to Ambulation

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

Study Arms (1)

Diagnostic Procedure

OTHER

Device: Diagnostic catheterization procedure

Interventions

Diagnostic catheterization procedure DEVICE

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

Diagnostic Procedure

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arstasis, Inc.: lead

Study Sites (8)

The Cardiovascular Center

Parker, Arizona, 85344, United States

Location

Sequoia Hospital

Redwood City, California, 94062, United States

Location

P&S Surgical Hospital

Monroe, Louisiana, 71201, United States

Location

Cardiovascular Institute of the South-Opelousas

Opelousas, Louisiana, 70570, United States

Location

Willis-Knighton Hospital

Shreveport, Louisiana, 71103, United States

Location

The Cooper Health System

Camden, New Jersey, 08103, United States

Location

Mercy Hospital Fairfield

Fairfield, Ohio, 45014, United States

Location

Volunteer Research Group, LLC

Knoxville, Tennessee, 37920, United States

Location

Related Publications (1)

• 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.

  PMID: 23293169 DERIVED

Results Point of Contact

• Title: Debra Cogan, Director of Quality, Regulatory and Clinical
• Organization: Arstasis

dcogan@arstasis.com

650-261-8073

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2011
• First Posted: January 7, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: January 31, 2013
• Results First Posted: January 17, 2013

Record last verified: 2013-01

Locations

US (8)