VASCADE ANTEGRADE-PVD Post-Market Registry
Study Details
Study Description
Brief Summary
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Due to the growing adoption of antegrade femoral access and the use of VCDs to close these arteriotomies, it is important to collect performance and complication outcomes data related to this procedural variable. The aim of this registry is to consistently collect prospective data on procedural outcomes on antegrade access cases closed with the VASCADE VCS in a way that is consistent with the RESPECT Study design and the FDA-approved Instructions for Use (IFU).
Study Design
Outcome Measures
Primary Outcome Measures
- Time to Hemostasis (TTH) [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.
- Major Access Site Closure-related Complications [Through 30 days +/- 7 days]
Patient incident rate of combined major access site closure-related complications through 30 days
Secondary Outcome Measures
- Time to Ambulation (TTA) [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.
- Time to Discharge (TTD) [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.
- Device Success [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.
- Procedure Success [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.
- Minor Access Site Closure-related Complications [Through 30 +/- 7 days]
Patient incident rate of combined minor access site closure-related complications through 30 days
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Acceptable candidate for post-procedural manual compression
-
Able to ambulate at least 20 feet, with or without assistance
Exclusion Criteria:
-
Active systemic or cutaneous infection or inflammation
-
Ipsilateral femoral arteriotomy with any of the following conditions: a) access within < or = 10 days; b) any residual hematoma, significant bruising, or known associated vascular complications; or c) within < or = 90 days, use of an intra-vascular closure device (i.e., Angioseal)
-
Previous vascular grafts or surgery at the target vessel access site
-
Major amputation of ipsilateral lower extremity - previous history of, or planned within next 30 days prior to study exit
-
Extreme morbid obesity (BMI greater than 4 kg/m2) or underweight (BMI less than 20 kg/m2)
-
Femoral arterial diameter < 6 mm at access site
-
Antegrade arterial access site is a side stick and/or is not a single anterior wall femoral puncture
-
Length of tissue tract, the distance between the anterior arterial wall and skin, is < 2.5 cm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cardiovascular Institute of the South | Houma | Louisiana | United States | 70360 |
| 2 | North MS Medical Center | Tupelo | Mississippi | United States | 38801 |
| 3 | Coastal Surgery Specialists | Wilmington | North Carolina | United States | 28401 |
| 4 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 5 | San Antonio Endovascular and Heart Institute | San Antonio | Texas | United States | 78258 |
Sponsors and Collaborators
- Cardiva Medical, Inc.
Investigators
- Principal Investigator: Mehdi Shishehbor, MD, The Cleveland Clinic
Study Documents (Full-Text)
More Information
Publications
- PTL 0502-02
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 52 |
| COMPLETED | 52 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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 Participants | 52 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
66.7
(9.86)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
17
32.7%
|
| Male |
35
67.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
9
17.3%
|
| Not Hispanic or Latino |
41
78.8%
|
| Unknown or Not Reported |
2
3.8%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
1
1.9%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
5
9.6%
|
| White |
46
88.5%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| BMI (Body Mass Index) (kg/m^2) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [kg/m^2] |
28.3
(4.46)
|
Outcome Measures
| Title | Time to Hemostasis (TTH) |
|---|---|
| Description | Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis. |
| Time Frame | Procedural, usually within 15 minutes of enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 52 |
| Mean (Standard Deviation) [minutes] |
5.87
(2.44)
|
| Title | Major Access Site Closure-related Complications |
|---|---|
| Description | Patient incident rate of combined major access site closure-related complications through 30 days |
| Time Frame | Through 30 days +/- 7 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 52 |
| Count of Participants [Participants] |
1
1.9%
|
| Title | Time to Ambulation (TTA) |
|---|---|
| Description | 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. |
| Time Frame | Prior to discharge, usually within 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 52 |
| Mean (Standard Deviation) [hours] |
4.48
(3.83)
|
| Title | Time to Discharge (TTD) |
|---|---|
| Description | Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility. |
| Time Frame | Through hospital discharge, usually within 24 hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 52 |
| Mean (Standard Deviation) [hours] |
5.97
(5.85)
|
| Title | Device Success |
|---|---|
| Description | 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. |
| Time Frame | Procedural, usually within 15 minutes of enrollment |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 52 |
| Count of Participants [Participants] |
51
98.1%
|
| Title | Procedure Success |
|---|---|
| Description | Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days. |
| Time Frame | Through 30 +/- 7 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 51 |
| Count of Participants [Participants] |
50
96.2%
|
| Title | Minor Access Site Closure-related Complications |
|---|---|
| Description | Patient incident rate of combined minor access site closure-related complications through 30 days |
| Time Frame | Through 30 +/- 7 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | VASCADE VCS |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 52 |
| Count of Participants [Participants] |
51
98.1%
|
Adverse Events
| Time Frame | 30 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | VASCADE VCS | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| VASCADE VCS | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/52 (0%) | |
Serious Adverse Events |
||
| VASCADE VCS | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/52 (3.8%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 2/52 (3.8%) | 2 |
| Infections and infestations | ||
| Chronic osteomyelitis of ankle/foot | 1/52 (1.9%) | 1 |
| Sepsis | 1/52 (1.9%) | 1 |
| Renal and urinary disorders | ||
| Acute Kidney Injury | 1/52 (1.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| VASCADE VCS | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/52 (21.2%) | |
| Blood and lymphatic system disorders | ||
| Access site arterial re-bleeding after initial hemostasis | 1/52 (1.9%) | 1 |
| Residual hematoma < 6 cm | 2/52 (3.8%) | 2 |
| Cardiac disorders | ||
| Pseudoaneurysm not requiring repair | 1/52 (1.9%) | 1 |
| Angina | 1/52 (1.9%) | 1 |
| Hypotension | 1/52 (1.9%) | 1 |
| General disorders | ||
| Mechanical Fall | 1/52 (1.9%) | 1 |
| Infections and infestations | ||
| Tissue tract oozing - prolonged | 2/52 (3.8%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Bruising | 1/52 (1.9%) | 1 |
| Surgical and medical procedures | ||
| Groin pain | 1/52 (1.9%) | 1 |
| Vascular disorders | ||
| Worsening PVD | 4/52 (7.7%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Terry Alverson, Director of Regulatory and Clinical |
|---|---|
| Organization | Cardiva Medical |
| Phone | 408-470-7119 |
| Terry_Alverson@cardivamedical.com |
- PTL 0502-02