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OpenTrials
Completed

NCT Number: NCT04745624

Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With CFA Disease

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.

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Key information

Conditions

Common Femoral Artery Stenosis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Adequate hemostasis - (efficacy)

    Time frame: within an hour immediately after procedure

    No evidence of bleeding after device use

  2. No complications after procedure - (safety)

    Time frame: early (48 hours)

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

  3. No complications after procedure - (safety)

    Time frame: late (30-day)

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Real World Use and Outcomes of VASCADE Closure Device Versus Manual Compression in Patients With Common Femoral Artery Disease: A Retrospective Comparison Study

Acronym: VASCADE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 9, 2021
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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