Accelerated Ambulation After Vascular Access Closure Device

NCT03142126 | Completed

• 1 other identifier: 548976
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Angiography; Heart Catheterization

Outcome Measures

Primary Outcomes (1)

• Failure of device to achieve hemostasis

  Continued bleeding after deployment prior to discharge

  20 minutes after procedure

Secondary Outcomes (2)

• Pseudoaneurysm

  7-10 days after discharge

• Groin hematoma

  7-10 days after discharge

Study Arms (1)

Early Ambulation

EXPERIMENTAL

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

Device: Early ambulation with Angioseal closure device

Interventions

Early ambulation with Angioseal closure device DEVICE

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

Also known as: Angioseal

Early Ambulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Henry Ford Health System: lead
• Providence Hospital: collaborator

Related Publications (3)

• 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.

  PMID: 22858390 BACKGROUND

• 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.

  PMID: 21470671 BACKGROUND

• 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.

  PMID: 29421959 DERIVED

MeSH Terms

Interventions

Early Ambulation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Marcel E Zughaib, MD

  Program Director-Physician Residency

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will receive early ambulation.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: August 6, 2014
• Primary Completion: August 5, 2015
• Study Completion: September 5, 2015
• Last Updated: December 19, 2025

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share