NCT04745624

Brief 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. An institutional procedural database, based on electronic medical record information will be abstracted to collect this information.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

February 4, 2021

Last Update Submit

February 2, 2022

Conditions

Common Femoral Artery Stenosis

Outcome Measures

Primary Outcomes (3)

  • Adequate hemostasis - (efficacy)

    No evidence of bleeding after device use

    within an hour immediately after procedure

  • No complications after procedure - (safety)

    Early complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality

    early (48 hours)

  • No complications after procedure - (safety)

    Late complications rates: bleeding, thrombosis, pseudoaneurysm, arterio-venous fistula, access site infection, mortality

    late (30-day)

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • , 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University

New Haven, Connecticut, 06519, United States

Location

Related Publications (3)

  • 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.

    PMID: 21810667BACKGROUND

  • Noori 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.

    PMID: 30146036BACKGROUND

  • Arora 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.

    PMID: 17383300BACKGROUND

Study Officials

  • Carlos Mena-Hurtado, MD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Kim Smolderen

    Yale University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2021

First Posted

February 9, 2021

Study Start

August 20, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)