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

NCT ID: NCT01271946

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 351 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2011-05-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic Procedure

Group Type: OTHER

Diagnostic catheterization procedure

Intervention Type: DEVICE

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

Interventions

Diagnostic catheterization procedure

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

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arstasis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zoltan Turi, MD

Role: PRINCIPAL_INVESTIGATOR

The Cooper Health System

John Held, MD

Role: PRINCIPAL_INVESTIGATOR

Mercy Hospital Fairfield

Frank Kresock, MD

Role: PRINCIPAL_INVESTIGATOR

The Cardiovascular Center

Tom Hinohara, MD

Role: PRINCIPAL_INVESTIGATOR

Sequoia Hospital

Dale Wortham, MD

Role: PRINCIPAL_INVESTIGATOR

Volunteer Research Group, LLC

Greg Sampognaro, MD

Role: PRINCIPAL_INVESTIGATOR

P&S

Ray Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Ark-La-Tex Cardiology/Willis-Knighton Hospital

Kalyan Veerina, MD

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute of the South-Opelousas

Locations

The Cardiovascular Center

Parker, Arizona, United States

Sequoia Hospital

Redwood City, California, United States

P&S Surgical Hospital

Monroe, Louisiana, United States

Cardiovascular Institute of the South-Opelousas

Opelousas, Louisiana, United States

Willis-Knighton Hospital

Shreveport, Louisiana, United States

The Cooper Health System

Camden, New Jersey, United States

Mercy Hospital Fairfield

Fairfield, Ohio, United States

Volunteer Research Group, LLC

Knoxville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 23293169 (View on PubMed)

Other Identifiers

RC-03133

Identifier Type: -

Identifier Source: org_study_id