The objective of this trial is to demonstrate the safety and effectiveness of the Cardiva VASCADE™ Vascular Closure System (VCS) in sealing femoral arterial access sites. Hypothesis: The Cardiva VASCADE™ VCS provides times to hemostasis (TTH) and time to ambulation (TTA) results that are less than manual compression by a clinically meaningful and statistically significant margin. The rate of major access site-related complications with the Cardiva VASCADE™ VCS is non-inferior to the major complication rates of manual compression for sealing femoral arterial access sites.
A prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing femoral arterial access sites and providing reduced times to hemostasis and ambulation compared with manual compression at the completion of diagnostic or interventional endovascular procedures performed through 6 Fr or 7 Fr introducer sheaths. Subjects will be randomized in a 2:1 treatment device to control ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Standard of Care
Investigational Hemostatic Vascular Closure System
Thomas Hospital
Fairhope, Alabama, United States
Time to Hemostasis (TTH)
Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Time frame: Up to 1 hour
Rate of Combined Access Site-related Major Complications
Primary safety endpoint * Access site-related bleeding requiring transfusion; * Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft); * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; * Permanent access site-related nerve injury. (\> 30 days)
Time frame: 30 days +/- 7 days
Time to Ambulation (TTA)
Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding
Time frame: Up to 1 day
Time to Discharge Eligibility (TTDE)
Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team
Time frame: Up to 2 days
Time to Hospital Discharge (TTHD)
Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital
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Christiana Care
Newark, Delaware, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
St. John's Prairie Heart
Springfield, Illinois, United States
St. Vincent's Heart Center of Indiana
Indianapolis, Indiana, United States
King's Daughters Medical Center
Ashland, Kentucky, United States
Terrebonne General Medical Center
Houma, Louisiana, United States
Lafayette General Medical Center
Lafayette, Louisiana, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Tufts University
Boston, Massachusetts, United States
...and 11 more locations
Time frame: Up to 2 days
Device Success
Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression
Time frame: Up to 1 day
Procedure Success
Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days
Time frame: 30 days +/- 7 days
Rate of Combined Minor Access Site Complications
Secondary safety endpoint * Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis; * Access site-related hematoma \> 6 cm; * Late access site-related bleeding (following hospital discharge); * Ipsilateral lower extremity arterial emboli; * Ipsilateral deep vein thrombosis; * Access site-related vessel laceration; * Access site wound dehiscence; * Localized access site infection treated with intramuscular or oral antibiotics; * Arteriovenous fistula not requiring treatment; * Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; * Pseudoaneurysm not requiring treatment; * New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair; * Ipsilateral pedal pulse diminished by two grades or transiently lost.
Time frame: 30 days +/- 7 days