Common Femoral Artery StenosisVASCADENCT04745624
Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease
An observational study of Common Femoral Artery Stenosis, run by Yale University at 1 site in United States.
Trial summary
To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Common Femoral Artery Stenosis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- Adult, Older adult
Study population: This will be a retrospective review of medical records and angiograms of patients who underwent coronary and peripheral angiograms at one institution. Patients with CFA stenosis will be identified by review of their access site angiograms. The method use for hemostasis, characteristics and outcomes will be abstracted via review of medical records.
Who may be able to join
- 5, 6 or 7 Fr access within the CFA
- ACT < 300 seconds
- Age 18 - 90 years old
- Severe common femoral arterial disease Percent stenosis > 50, which will be core-lab adjudicated
Who cannot join
- Ipsilateral CFA access within 30 days preceding or subsequent to the index case
- Prior ipsilateral closure device use, other than VASCADE
- High bleeding risk ACT > 300 or > 250 with IIb/IIIa inhibitor Plt < 50K INR > 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure
- Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With Common Femoral Artery Disease: A Retrospective Comparison Study
To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.
Read the detailed description
The overall objective of the study will be to examine the safety and efficacy of the VASCADE closure device compared to manual compression (standard of care) to achieve hemostasis after endovascular procedures requiring access within a severely diseased CFA.
This study will be a retrospective single center review of 200 patients undergoing endovascular procedures utilizing vascular access within a severely diseased CFA between 2018 and 2020 at Yale New Haven Hospital. A random selection of patients undergoing hemostasis with manual compression (n = 100) and VASCADE vascular closure system (n = 100) will be conducted. The two groups will then be statistically compared with respect to 48-hour and 30-day safety and efficacy outcomes.
- Conditions
- Common Femoral Artery Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| manual compression cohort | Manual compression cohort: Patients who underwent coronary or peripheral angiograms via CFA access with moderate to severe stenosis were hemostasis was achieved via manual compression | |
| VASCADE cohort | VASCADE cohort: Patients who underwent coronary or peripheral angiograms via CFA access with moderate to severe stenosis were hemostasis was achieved via VASCADE device closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate hemostasis - (efficacy)
No evidence of bleeding after device use
Measured: within an hour immediately after procedure
No complications after procedure - (safety)
Early complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality
Measured: early (48 hours)
No complications after procedure - (safety)
Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality
Measured: late (30-day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start20 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Common Femoral Artery StenosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Mena-Hurtado, MD, Principal investigator, Yale UniversityKim Smolderen, Study director, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745624
- Sponsor's protocol ID
- 2000028947
- Acronym
- VASCADE
- Status last verified
- Feb 2022
- First submitted
- 4 Feb 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bangalore S, Bhatt DL. Femoral arterial access and closure. Circulation. 2011 Aug 2;124(5):e147-56. doi: 10.1161/CIRCULATIONAHA.111.032235. No abstract available.
PubMed 21810667Noori VJ, Eldrup-Jorgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018 Sep;68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29.
PubMed 30146036Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J. 2007 Apr;153(4):606-11. doi: 10.1016/j.ahj.2006.12.014.
PubMed 17383300
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With Common Femoral Artery Disease: A Retrospective Comparison Study
- ClinicalTrials.gov ID
- NCT04745624
- Acronym / sponsor ID
- VASCADE / 2000028947
- Conditions
- Common Femoral Artery Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the patient characteristics and outcomes associated with the real-world use of manual compression vs. vascular closure devices (VCDs) after common femoral artery (CFA) percutaneous access for coronary and endovascular interventions. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.
Detailed description
The overall objective of the study will be to examine the safety and efficacy of the VASCADE closure device compared to manual compression (standard of care) to achieve hemostasis after endovascular procedures requiring access within a severely diseased CFA.
This study will be a retrospective single center review of 200 patients undergoing endovascular procedures utilizing vascular access within a severely diseased CFA between 2018 and 2020 at Yale New Haven Hospital. A random selection of patients undergoing hemostasis with manual compression (n = 100) and VASCADE vascular closure system (n = 100) will be conducted. The two groups will then be statistically compared with respect to 48-hour and 30-day safety and efficacy outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manual compression cohort | – | –Manual compression cohort: Patients who underwent coronary or peripheral angiograms via CFA access with moderate to severe stenosis were hemostasis was achieved via manual compression |
| VASCADE cohort | – | –VASCADE cohort: Patients who underwent coronary or peripheral angiograms via CFA access with moderate to severe stenosis were hemostasis was achieved via VASCADE device closure |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This will be a retrospective review of medical records and angiograms of patients who underwent coronary and peripheral angiograms at one institution. Patients with CFA stenosis will be identified by review of their access site angiograms. The method use for hemostasis, characteristics and outcomes will be abstracted via review of medical records.
Key inclusion criteria (4 listed)
- 5, 6 or 7 Fr access within the CFA
- ACT < 300 seconds
- Age 18 - 90 years old
- Severe common femoral arterial disease Percent stenosis > 50, which will be core-lab adjudicated
Key exclusion criteria (4 listed)
- Ipsilateral CFA access within 30 days preceding or subsequent to the index case
- Prior ipsilateral closure device use, other than VASCADE
- High bleeding risk ACT > 300 or > 250 with IIb/IIIa inhibitor Plt < 50K INR > 1.7 on the day of procedure Inherent coagulopathy NOAC, warfarin, or lovenox administered within 24 hours of the procedure
- Suspected intraluminal thrombus, dissection, pseudoaneurysm, hematoma, or AV Fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adequate hemostasis - (efficacy)
Time frame: within an hour immediately after procedure
No evidence of bleeding after device use
No complications after procedure - (safety)
Time frame: early (48 hours)
Early complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality
No complications after procedure - (safety)
Time frame: late (30-day)
Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Background: PubMed 21810667Bangalore S, Bhatt DL. Femoral arterial access and closure. Circulation. 2011 Aug 2;124(5):e147-56. doi: 10.1161/CIRCULATIONAHA.111.032235. No abstract available.
- Background: PubMed 30146036Noori VJ, Eldrup-Jorgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018 Sep;68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29.
- Background: PubMed 17383300Arora N, Matheny ME, Sepke C, Resnic FS. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J. 2007 Apr;153(4):606-11. doi: 10.1016/j.ahj.2006.12.014.
- Individual participant dataSharing planned: No
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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.
Carlos Mena-Hurtado, MD principal investigator
Yale University
Kim Smolderen study director
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Common Femoral Artery Stenosis, run by Yale University at 1 site 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 4 inclusion and 4 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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adequate hemostasis - (efficacy) (time frame: within an hour immediately after procedure). The study lists 3 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 NCT04745624, which also lists 3 linked publications.
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 3 Feb 2022.