Surgical Wound
Conditions
Keywords
vascular closure system, manual compression, femoral arteriotomy, percutaneous endovascular procedures
Brief summary
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.
Detailed description
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.
Interventions
OTHERManual compression
Standard of Care
DEVICECardiva VASCADE™ Vascular Closure System
Investigational Hemostatic Vascular Closure System
Sponsors
Cardiva Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Pre-Operative Inclusion Criteria: * Patients undergoing an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 6 or 7 Fr introducer sheath Pre-Operative
Exclusion criteria
1. Advanced refusal of blood transfusion, if necessary; 2. Active systemic or a cutaneous infection or inflammation; 3. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids; 4. Known, significant history of bleeding diathesis, coagulopathy, von Willebrand's disease or current platelet count \< 100,000 cells/mm3, baseline INR ≥1.8, or fibrinogen level less than 150 mg/dl (if received a fibrinolytic agent within prior 24 hours); 5. Severe co-existing morbidities having a life expectancy of less than 30 days; 6. Currently involved in any other investigational clinical trial; 7. Ipsilateral femoral arteriotomy within the previous 30 days; 8. Planned endovascular procedure within the next 30 days; 9. Previous ipsilateral femoral artery closure using a permanent implant-based closure device; 10. Previous vascular grafts or surgery at the target vessel access site; 11. History of symptomatic peripheral arterial disease, revascularization or deep vein thrombosis in the ipsilateral limb; 12. Unilateral or bilateral lower extremity amputation(s); 13. Significant anemia with a hemoglobin level less than 10 g/dL or a hematocrit less than 30%; 14. Renal insufficiency (serum creatinine of \> 2.5 mg/dl); 15. Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating; 16. Extreme morbid obesity (BMI greater than 45 kg/m2) or underweight (BMI less than 20 kg/m2); 17. Unable to routinely walk at least 20 feet without assistance (see protocol); 18. Known allergy/adverse reaction to bovine derivatives, sodium hyaluronate or hyaluronan preparations; 19. Procedures that extend hospitalization (e.g., staged endovascular procedure, CABG); 20. Administration of low molecular weight heparin (LMWH) within 8 hours of the procedure. Intra-op
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis (TTH) | Up to 1 hour | Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis. |
| Rate of Combined Access Site-related Major Complications | 30 days +/- 7 days | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hospital Discharge (TTHD) | Up to 2 days | Secondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital |
| Device Success | Up to 1 day | Secondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression |
| Time to Ambulation (TTA) | Up to 1 day | 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 |
| Rate of Combined Minor Access Site Complications | 30 days +/- 7 days | 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. |
| Procedure Success | 30 days +/- 7 days | Secondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days |
| Time to Discharge Eligibility (TTDE) | Up to 2 days | 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 |
Countries
Australia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Manual Compression Manual compression: Standard of Care | 142 |
| VASCADE™ Vascular Closure System Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System | 275 |
| Total | 417 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | VASCADE™ Vascular Closure System | Total | Manual Compression |
|---|---|---|---|
| Age, Continuous | 61.8 years STANDARD_DEVIATION 11.2 | 62 years STANDARD_DEVIATION 10.8 | 62.5 years STANDARD_DEVIATION 10.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 24 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 249 Participants | 379 Participants | 130 Participants |
| Sex: Female, Male Female | 79 Participants | 120 Participants | 41 Participants |
| Sex: Female, Male Male | 196 Participants | 297 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 142 | 56 / 275 |
| serious Total, serious adverse events | 0 / 142 | 0 / 275 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Compression | Rate of Combined Access Site-related Major Complications | 0 participants |
| VASCADE™ Vascular Closure System | Rate of Combined Access Site-related Major Complications | 0 participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Compression | Time to Hemostasis (TTH) | 21.4 minutes | Standard Deviation 12.4 |
| VASCADE™ Vascular Closure System | Time to Hemostasis (TTH) | 4.8 minutes | Standard Deviation 5.4 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Compression | Device Success | 263 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Compression | Procedure Success | 142 participants |
| VASCADE™ Vascular Closure System | Procedure Success | 275 participants |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Manual Compression | Rate of Combined Minor Access Site Complications | 10 participants |
| VASCADE™ Vascular Closure System | Rate of Combined Minor Access Site Complications | 3 participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Compression | Time to Ambulation (TTA) | 5.8 hours | Standard Deviation 3.1 |
| VASCADE™ Vascular Closure System | Time to Ambulation (TTA) | 3.8 hours | Standard Deviation 5.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Compression | Time to Discharge Eligibility (TTDE) | 6.5 hours | Standard Deviation 3.3 |
| VASCADE™ Vascular Closure System | Time to Discharge Eligibility (TTDE) | 4.8 hours | Standard Deviation 6.4 |
Secondary
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
Time frame: Up to 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Compression | Time to Hospital Discharge (TTHD) | 13.7 hours | Standard Deviation 9.8 |
| VASCADE™ Vascular Closure System | Time to Hospital Discharge (TTHD) | 18.3 hours | Standard Deviation 34.5 |