Surgical WoundNCT02948257
VASCADE ANTEGRADE-PVD Post-Market Registry
An observational study of Surgical Wound, run by Cardiva Medical, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Wound
- What is being tested?
- Cardiva Medical VASCADE VCS
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Jan 2017to 18 Sep 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath
Who may be able to join
- Acceptable candidate for post-procedural manual compression
- Able to ambulate at least 20 feet, with or without assistance
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Cardiovascular Institute of the South
Houma, Louisiana, 70360
San Antonio Endovascular and Heart Institute
San Antonio, Texas, 78258
North MS Medical Center
Tupelo, Mississippi, 38801
Coastal Surgery Specialists
Wilmington, North Carolina, 28401
About this study
Official title: Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.
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.
Read the 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).
- Conditions
- Surgical Wound
- Being tested
- Cardiva Medical VASCADE VCS
- Keywords
- Vessel closure, Antegrade access, Femoral arteriotomy, Peripheral endovascular interventions
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiva Medical VASCADE VCSDevice
At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Hemostasis (TTH)
Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
Measured: Procedural, usually within 15 minutes of enrollment
Major Access Site Closure-related Complications
Patient incident rate of combined major access site closure-related complications through 30 days
Measured: Through 30 days +/- 7 days
Secondary outcomes (5)
Time to Ambulation (TTA)
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.
Measured: Prior to discharge, usually within 24 hours
Time to Discharge (TTD)
Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.
Measured: Through hospital discharge, usually within 24 hours
Device Success
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.
Measured: Procedural, usually within 15 minutes of enrollment
Procedure Success
Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.
Measured: Through 30 +/- 7 days
Minor Access Site Closure-related Complications
Patient incident rate of combined minor access site closure-related complications through 30 days
Measured: Through 30 +/- 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study start19 Jan 2017
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Cardiva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mehdi Shishehbor, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948257
- Sponsor's protocol ID
- PTL 0502-02
- Status last verified
- Jan 2020
- First submitted
- 26 Oct 2016
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.
PubMed 25740963
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, PM Registry for Procedural Outcomes Using the Cardiva VASCADE VCS for Closing the Femoral Arteriotomy After Percutaneous Endovascular Procedures Via Antegrade Access.
- ClinicalTrials.gov ID
- NCT02948257
- Acronym / sponsor ID
- PTL 0502-02
- Conditions
- Surgical Wound
- Keywords
- Vessel closure, Antegrade access, Femoral arteriotomy, Peripheral endovascular interventions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cardiva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jan 2017 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acceptable candidate for an elective, non-emergent ipsilateral peripheral interventional endovascular procedure via antegrade access of the femoral artery using a 5, 6 or 7 Fr introducer sheath
Key inclusion criteria (2 listed)
- Acceptable candidate for post-procedural manual compression
- Able to ambulate at least 20 feet, with or without assistance
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiva Medical VASCADE VCSAt the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis. | Device | – |
Primary outcome
Time to Hemostasis (TTH)
Time frame: 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
Time frame: Through 30 days +/- 7 days
Patient incident rate of combined major access site closure-related complications through 30 days
5 secondary outcomes
Time to Ambulation (TTA)
Time frame: Prior to discharge, usually within 24 hours
Time to Discharge (TTD)
Time frame: Through hospital discharge, usually within 24 hours
Device Success
Time frame: Procedural, usually within 15 minutes of enrollment
Procedure Success
Time frame: Through 30 +/- 7 days
Minor Access Site Closure-related Complications
Time frame: Through 30 +/- 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25740963Hermiller JB, Leimbach W, Gammon R, Karas SP, Whitbourn RJ, Wong SC, Goswami N, McCabe J, Cavros NG, Paulus R, Naidu SS, Turi ZG. A prospective, randomized, pivotal trial of a novel extravascular collagen-based closure device compared to manual compression in diagnostic and interventional patients. J Invasive Cardiol. 2015 Mar;27(3):129-36.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Shishehbor, MD principal investigator
The Cleveland Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound, run by Cardiva Medical, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Hemostasis (TTH) (time frame: Procedural, usually within 15 minutes of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.