Clinical trial NCT01271946: A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System
Official title: A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnostic Catheterization Access Through a 5F or 6F Femoral Artery Introducer
Lead sponsor: Arstasis, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Observation of Any Site Related Complications Recorded as Either Major or Minor Adverse Events.
timeFrame: Procedure through 30 days follow-up.
measure: Major Adverse Events Reported as Percentage of Participants With Adverse Events.
timeFrame: Procedure through 30 day follow-up.
measure: Device Success
timeFrame: Procedure
measure: Minor Adverse Events
timeFrame: Procedure through 30 day follow-up.
measure: Time to Hemostasis
timeFrame: Hemostasis was evaluated immediately following procedural sheath removal until hemostasis was achieved.
measure: Time to Discharge Eligibility
timeFrame: Discharge Eligibility was evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.
measure: Time to Actual Discharge
timeFrame: Actual discharge was evaluated following procedural sheath removal until actual discharge, an average time of 9.3 hours.
measure: Time to Ambulation
timeFrame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
measure: Percentage of Participants With Bed Elevation Within 15 Minutes.
timeFrame: Post procedure
Secondary outcomes:
measure: Time to Hemostasis
timeFrame: Hemostasis was evaluated immediately following procedural sheath removal.
measure: Time to Ambulation
timeFrame: Ambulation was evaluated at any time after 1, 2 and 4 hours post sheath removal, until the subject was successfully ambulated.
Other outcomes:
Locations:
city: Parker
country: United States
facility: The Cardiovascular Center
state: Arizona
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Monroe
country: United States
facility: P&S Surgical Hospital
state: Louisiana
city: Opelousas
country: United States
facility: Cardiovascular Institute of the South-Opelousas
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Hospital
state: Louisiana
city: Camden
country: United States
facility: The Cooper Health System
state: New Jersey
city: Fairfield
country: United States
facility: Mercy Hospital Fairfield
state: Ohio
city: Knoxville
country: United States
facility: Volunteer Research Group, LLC
state: Tennessee
Study officials:
affiliation: The Cooper Health System
name: Zoltan Turi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Hospital Fairfield
name: John Held, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cardiovascular Center
name: Frank Kresock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sequoia Hospital
name: Tom Hinohara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Volunteer Research Group, LLC
name: Dale Wortham, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: P&S
name: Greg Sampognaro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ark-La-Tex Cardiology/Willis-Knighton Hospital
name: Ray Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Institute of the South-Opelousas
name: Kalyan Veerina, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.