Access Safety and Efficacy Post Endovascular Intervention

NCT01773148 | Unknown DMC

• 1 other identifier: RC-03773
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 17

Brief Summary

The goal of this study is to assess the safety and effectiveness of the AXERA Access System in subjects undergoing Common Femoral Artery (CFA) access for Percutaneous Coronary Intervention (PCI) and/or Peripheral Vascular Intervention (PVI) through a 5 French (F) or 6F introducer sheath.

Conditions

Cardiovascular Disease.

Outcome Measures

Primary Outcomes (2)

• Major Adverse Events

  Absence of major access site-related complications.

  Procedure through 30 day follow-up.

• Device Success

  Defined as: * Successful placement of AXERA followed by procedural sheath * Achievement of hemostasis in conjunction with manual or mechanical compression

  Day 1-Day of Procedure.

Secondary Outcomes (5)

• Time to Hemostasis (TTH)

  Immediately following procedural sheath removal.

• Time to Ambulation (TTA)

  Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated.

• Time to Discharge, eligibility (TTD/e)

  Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.

• Time to Discharge, actual (TTD/a)

  Evaluated following procedural sheath removal until actual discharge.

• Minor Adverse Events

  Procedure through 30 day follow-up.

Study Arms (1)

Arstasis Access System (AXERA) placement

EXPERIMENTAL

Placement of AXERA device in subjects undergoing common femoral artery access for PCI and/or PVI through a 5F or 6F introducer sheath.

Device: Arstasis Access System (AXERA)

Interventions

Arstasis Access System (AXERA) DEVICE

Placement of the AXERA device in the Femoral Artery.

Arstasis Access System (AXERA) placement

Eligibility Criteria

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

You may qualify if:

• Subject is 18 years of age or older.
• Subject is clinically indicated for a PCI or PVI involving access through a 5F or 6F introducer sheath in the femoral artery.
• Subject is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) within 2 hours post procedure.
• Female subjects of child bearing potential must have a negative pregnancy test.

You may not qualify if:

• Subjects who are pregnant or lactating.
• Subject has a pre-existing severe non-cardiac systemic disease/illness or another reason that results in a projected life expectancy of less than 1 year.
• Subject has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
• Subject has systemic hypertension unresponsive to treatment (\>180mmHg systolic and \>110mm diastolic).
• Subject has significant bleeding coagulopathy or platelet disorder, (INR\> 2.0), including known thrombocytopenia (platelet count \<100,000/µL), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (hemoglobin \<10 g/dL, or hematocrit \<30%).
• Subject presents with chronic renal insufficiency (creatinine ≥3.0mg/dl).
• Subject presents with hemodynamic instability or is in need of emergent surgery or emergent procedure.
• Subject presents with ST elevation myocardial infarction.
• Subject presents with unstable angina or non-ST elevation myocardial infarction and has troponin level \> 3 X upper limit of normal. There must be at least one troponin level drawn \> 6 hours after onset of chest pain.
• Subject has received low molecular weight heparin \< 8 hours before vascular access, glycoprotein IIb/IIIa inhibitor \< 24 hours before vascular access, unfractionated heparin by infusion \< 1 hour before vascular access, or parenteral heparin at anticoagulant dose (as opposed to DVT prophylaxis)\< 6 hours before vascular access.
• Subjects who are clinically obese, defined as BMI \>40.
• Subject has received femoral artery Vessel Closure Implant (VCI) (suture or staple) at the target access site.
• Subject has received femoral artery VCI (collagen/PEG/PGA) at the target access site within 90 days of AXERA procedure.
• Subject is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize, is leg amputee or has known paralysis) or unable to ambulate within 2 hours post procedure.
• Subject has had prior vascular surgery or vascular grafts at the target femoral artery access site.

Sponsors & Collaborators

• Arstasis, Inc.: lead

Study Sites (17)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Scripps Green

La Jolla, California, 92037, United States

Location

Loma Linda University Health

Loma Linda, California, 92354, United States

Location

Mercy Heart and Vascular Institute

Sacramento, California, 95816, United States

Location

St. Joseph's Medical Center

Stockton, California, 95204, United States

Location

Christiana Care

Newark, Delaware, 19713, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Opelousas General Health System

Opelousas, Louisiana, 70570, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Northern Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Rose Dominican

Las Vegas, Nevada, 89113, United States

Location

St. John Medical Center

Tulsa, Oklahoma, 74104, United States

Location

AnMed Health

Anderson, South Carolina, 29621, United States

Location

Lexington Medical Center

West Columbia, South Carolina, 29169, United States

Location

Franciscan Research Center

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Mark Dorogy, MD

  The Medical Center of Central Georgia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 23, 2013
• Study Start: December 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 24, 2015

Record last verified: 2015-02

Locations

US (17)