Trial Outcomes & Findings for VASCADE ANTEGRADE-PVD Post-Market Registry (NCT NCT02948257)

NCT ID: NCT02948257

Last Updated: 2020-01-18

Results Overview

Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.

• Recruitment status: COMPLETED
• Target enrollment: 52 participants
• Primary outcome timeframe: Procedural, usually within 15 minutes of enrollment
• Results posted on: 2020-01-18

Participant Flow

Participant milestones

Measure	VASCADE VCS The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Overall Study STARTED	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

VASCADE ANTEGRADE-PVD Post-Market Registry

Baseline characteristics by cohort

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Age, Continuous	66.7 years STANDARD_DEVIATION 9.86 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI (Body Mass Index)	28.3 kg/m^2 STANDARD_DEVIATION 4.46 • n=5 Participants

PRIMARY outcome

Timeframe: Procedural, usually within 15 minutes of enrollment

Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.

Outcome measures

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Time to Hemostasis (TTH)	5.87 minutes Standard Deviation 2.44

PRIMARY outcome

Timeframe: Through 30 days +/- 7 days

Patient incident rate of combined major access site closure-related complications through 30 days

Outcome measures

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Major Access Site Closure-related Complications	1 Participants

SECONDARY outcome

Timeframe: Prior to discharge, usually within 24 hours

Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.

Outcome measures

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Time to Ambulation (TTA)	4.48 hours Standard Deviation 3.83

SECONDARY outcome

Timeframe: Through hospital discharge, usually within 24 hours

Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.

Outcome measures

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Time to Discharge (TTD)	5.97 hours Standard Deviation 5.85

SECONDARY outcome

Timeframe: Procedural, usually within 15 minutes of enrollment

Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.

Outcome measures

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Device Success	51 Participants

SECONDARY outcome

Timeframe: Through 30 +/- 7 days

Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.

Outcome measures

Measure	VASCADE VCS n=51 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Procedure Success	50 Participants

SECONDARY outcome

Timeframe: Through 30 +/- 7 days

Patient incident rate of combined minor access site closure-related complications through 30 days

Outcome measures

Measure	VASCADE VCS n=52 Participants The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Minor Access Site Closure-related Complications	51 Participants

Adverse Events

VASCADE VCS

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	VASCADE VCS n=52 participants at risk The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Infections and infestations Chronic osteomyelitis of ankle/foot	1.9% 1/52 • Number of events 1 • 30 days
Blood and lymphatic system disorders Anemia	3.8% 2/52 • Number of events 2 • 30 days
Infections and infestations Sepsis	1.9% 1/52 • Number of events 1 • 30 days
Renal and urinary disorders Acute Kidney Injury	1.9% 1/52 • Number of events 1 • 30 days

Other adverse events

Measure	VASCADE VCS n=52 participants at risk The Cardiva VASCADETM Vascular Closure System (VCS) was used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7 Fr introducer sheaths via an antegrade approach.
Blood and lymphatic system disorders Access site arterial re-bleeding after initial hemostasis	1.9% 1/52 • Number of events 1 • 30 days
Blood and lymphatic system disorders Residual hematoma < 6 cm	3.8% 2/52 • Number of events 2 • 30 days
Infections and infestations Tissue tract oozing - prolonged	3.8% 2/52 • Number of events 2 • 30 days
Cardiac disorders Pseudoaneurysm not requiring repair	1.9% 1/52 • Number of events 1 • 30 days
Skin and subcutaneous tissue disorders Bruising	1.9% 1/52 • Number of events 1 • 30 days
Surgical and medical procedures Groin pain	1.9% 1/52 • Number of events 1 • 30 days
Cardiac disorders Angina	1.9% 1/52 • Number of events 1 • 30 days
Vascular disorders Worsening PVD	7.7% 4/52 • Number of events 4 • 30 days
Cardiac disorders Hypotension	1.9% 1/52 • Number of events 1 • 30 days
General disorders Mechanical Fall	1.9% 1/52 • Number of events 1 • 30 days

Additional Information

Terry Alverson, Director of Regulatory and Clinical

Cardiva Medical

Phone: 408-470-7119

Email: Terry_Alverson@cardivamedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60