Access Safety and Efficacy Post Endovascular Intervention

Cardiovascular Disease. Clinical Trial

— ASPEN  

Official title:

AXERA Access Safety and Efficacy Post Endovascular INtervention

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01773148
• Other study ID #: RC-03773
• Status: Active, not recruiting
• Phase: N/A
• First received: January 15, 2013
• Last updated: February 23, 2015
• Start date: December 2012
• Est. completion date: June 2015

Study information

• Verified date: February 2015
• Source: Arstasis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease.
• Cardiovascular Diseases

Intervention

Device:
• Arstasis Access System (AXERA)
Placement of the AXERA device in the Femoral Artery.

Locations

Country	Name	City	State
United States	AnMed Health	Anderson	South Carolina
United States	Sinai Hospital	Baltimore	Maryland
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Heart Center Research, LLC	Huntsville	Alabama
United States	Scripps Green	La Jolla	California
United States	St. Rose Dominican	Las Vegas	Nevada
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Loma Linda University Health	Loma Linda	California
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Christiana Care	Newark	Delaware
United States	Opelousas General Health System	Opelousas	Louisiana
United States	Mercy Heart and Vascular Institute	Sacramento	California
United States	St. Joseph's Medical Center	Stockton	California
United States	Franciscan Research Center	Tacoma	Washington
United States	St. John Medical Center	Tulsa	Oklahoma
United States	Northern Mississippi Medical Center	Tupelo	Mississippi
United States	Lexington Medical Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arstasis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events	Absence of major access site-related complications.	Procedure through 30 day follow-up.	Yes
Primary	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.	No
Secondary	Time to Hemostasis (TTH)	Elapsed time between sheath removal and first observed hemostasis.	Immediately following procedural sheath removal.	No
Secondary	Time to Ambulation (TTA)	Elapsed time between sheath removal to time when subject stands and walks at least 20 feet without re-bleeding.	Evaluated at any time after 2 hours post sheath removal, until the subject successfully ambulated.	No
Secondary	Time to Discharge, eligibility (TTD/e)	Elapsed time between sheath removal and the time when subject is medically able to be discharged.	Evaluated following sheath removal and ambulation and physical examination of the access site demonstrating stable access site.	No
Secondary	Time to Discharge, actual (TTD/a)	Elapsed time between sheath removal and the actual time when subject is discharged.	Evaluated following procedural sheath removal until actual discharge.	No
Secondary	Minor Adverse Events	Combined rate of minor vascular access-site related complications.	Procedure through 30 day follow-up.	Yes