This study evaluates the safety and effectiveness of the Cross-Seal vascular closure device in gaining post procedure hemostasis in subjects undergoing interventional procedures requiring an 8 to 18 french size introducer sheath.
The Cross-Seal device is a VCD intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (8-18F ID) interventional devices. The function of Cross-Seal is to percutaneously close the puncture in the artery wall (arteriotomy) through which the catheters were inserted for the procedure. The study is being conducted to demonstrate the safety and effectiveness of Cross-Seal in achieving hemostasis in femoral arterial access sites in subjects undergoing percutaneous transcatheter interventional procedures using a large-bore procedure sheath.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Use of the Cross-Seal system to close the femoral arteriotomy
Vascular Institute of the Rockies
Denver, Colorado, United States
Freedom From Major Complications
Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection
Time frame: 30 days post procedure
Mean Time To Hemostasis (TTH)
The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.
Time frame: Index Procedure
Freedom From Minor Complications
The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence
Time frame: 30 days post procedure
Number of Participants With Device Related Complications Within 30 Days Post-procedure
Number of subjects with devices related complications as adjudicated by the Clinical Events Committee.
Time frame: 30 days post procedure
Incidence of Adverse Events
Incidence of major and minor Adverse Events (AEs)
Time frame: 60 days post procedure
Incidence of Technical Success
Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).
Time frame: Immediately Post-procedure (procedure approximately 8 hours)
Incidence of Closure Success
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
River City Clinical Research
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Iowa Hospital
Iowa City, Iowa, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Rutgers, The State University of New Jersey
Piscataway, New Jersey, United States
Mt Sinai Medical Center
New York, New York, United States
The Trustees of Columbia University in the City of New York
New York, New York, United States
University of Rochester
Rochester, New York, United States
Good Samaritan Hospital
Cincinnati, Ohio, United States
...and 10 more locations
Incidence of access site closure success: defined as technical success and freedom from major complications
Time frame: Within 48 hours of the index procedure or hospital discharge, whichever occurs first
Incidence of Treatment Success
Incidence of Treatment Success: defined as technical success and freedom from major complications
Time frame: 30 days post procedure
Incidence of Surgical or Endovascular Intervention Post Closure
Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.
Time frame: 30 days post procedure
Incidence of Manual Compression
Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).
Time frame: Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours
Time-to-Ambulation:
Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.
Time frame: From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours
Incidence of Device Failure
Incidence of subjects experiencing Device Failure.
Time frame: 30 days post procedure
Incidence of Procedure Related Complications
Number of subjects with procedure related complications as adjudicated by the CEC.
Time frame: 30 days post procedure