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Accelerated Ambulation After Vascular Access Closure Device

NCT ID: NCT03142126

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-06

Study Completion Date

2015-09-05

Brief Summary

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The researchers are seeking to study whether or not there is benefit in keeping patients flat after Angioseal for extended periods of time after diagnostic heart catheterization or if a more aggressive approach of early ambulation would be just as safe while improving cost and patient comfort.

Detailed Description

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Diagnostic left heart catheterization is the gold standard to assess coronary anatomy. A number of post procedure closure devices have been used in order to be able to ambulate patients after the procedure. Without closure device of the arterial sheath the typical time a patient must lay flat following a diagnostic left heart catheterization at Providence hospital is approximately six hours. This extended time of having to lie flat for the patient is both uncomfortable and time consuming for hospital employees.

The Angioseal closure device is a vascular plug that has been approved by the FDA in order to seal the femoral artery arteriotomy and allow for a faster ambulation time after cardiac catheterization. Currently, the Angioseal device has been approved for ambulation times of 20 minutes after diagnostic left heart catheterization but a more conservative approach is typically used after device. A very common strategy after Angioseal is to keep the patient flat for 2 hours prior to ambulation and then to keep the patient another hour after ambulation for observation of the femoral site.

While a conservative strategy may be considered safer to the operator the Angioseal device has already been approved for an early ambulation strategy. The goal of this study is to reaffirm the safety and efficacy of using Angioseal for early ambulation. If early ambulation is performed it could improve patient comfort and even reduce cost.

Conditions

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Coronary Angiography Heart Catheterization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Eligible patients will receive early ambulation.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early Ambulation

To affirm the safety and efficacy of ambulation of 20 minutes after diagnostic left heart catheterization.

Group Type EXPERIMENTAL

Early ambulation with Angioseal closure device

Intervention Type DEVICE

To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy

Interventions

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Early ambulation with Angioseal closure device

To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy

Intervention Type DEVICE

Other Intervention Names

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Angioseal

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Patients undergoing diagnostic left heart catheterization.

Exclusion Criteria: Patients who do not meet criteria for Angioseal closure after diagnostic left heart catheterization.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Providence Hospital

OTHER

Sponsor Role collaborator

Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcel E Zughaib, MD

Role: STUDY_DIRECTOR

Program Director-Physician Residency

References

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Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial versus femoral randomized investigation in ST-segment elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2481-9. doi: 10.1016/j.jacc.2012.06.017. Epub 2012 Aug 1.

Reference Type BACKGROUND
PMID: 22858390 (View on PubMed)

Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

Reference Type BACKGROUND
PMID: 21470671 (View on PubMed)

Brancheau D, Sarsam S, Assaad M, Zughaib M. Accelerated ambulation after vascular access closure device. Ther Adv Cardiovasc Dis. 2018 May;12(5):141-144. doi: 10.1177/1753944718756604. Epub 2018 Feb 8.

Reference Type DERIVED
PMID: 29421959 (View on PubMed)

Other Identifiers

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548976

Identifier Type: -

Identifier Source: org_study_id