Access Safety and Efficacy Post Endovascular Intervention

NCT ID: NCT01773148

Last Updated: 2015-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2015-06-30

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.

Study Design

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

Study Groups

Arstasis Access System (AXERA) placement

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

Group Type: EXPERIMENTAL

Arstasis Access System (AXERA)

Intervention Type: DEVICE

Placement of the AXERA device in the Femoral Artery.

Interventions

Arstasis Access System (AXERA)

Placement of the AXERA device in the Femoral Artery.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.
• Subject has had a previous target femoral artery complication from angiography (such as pseudoaneurysm, Arteriovenous (AV) fistula, dissection), small CFA, abnormal, absent or weak distal ipsilateral pulse, or presenting with clinically significant peripheral vascular disease in the vicinity of the puncture.
• Subject has a high puncture (i.e. above the inferior reflection of the inferior epigastric artery).
• Subject has antegrade puncture.
• Subject has a stent in the ipsilateral common femoral artery.
• Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.

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

Sponsors

Arstasis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Dorogy, MD

Role: PRINCIPAL_INVESTIGATOR

The Medical Center of Central Georgia

Locations

Heart Center Research, LLC

Huntsville, Alabama, United States

Arkansas Heart Hospital

Little Rock, Arkansas, United States

Scripps Green

La Jolla, California, United States

Loma Linda University Health

Loma Linda, California, United States

Mercy Heart and Vascular Institute

Sacramento, California, United States

St. Joseph's Medical Center

Stockton, California, United States

Christiana Care

Newark, Delaware, United States

Medical Center of Central Georgia

Macon, Georgia, United States

Opelousas General Health System

Opelousas, Louisiana, United States

Sinai Hospital

Baltimore, Maryland, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Northern Mississippi Medical Center

Tupelo, Mississippi, United States

St. Rose Dominican

Las Vegas, Nevada, United States

St. John Medical Center

Tulsa, Oklahoma, United States

AnMed Health

Anderson, South Carolina, United States

Lexington Medical Center

West Columbia, South Carolina, United States

Franciscan Research Center

Tacoma, Washington, United States

Countries

United States

Other Identifiers

RC-03773

Identifier Type: -

Identifier Source: org_study_id