CClinicalTrials.gg
Status unknownNCT03182530Updated Jun 9, 2017

Prevention of Radial Artery Occlusion After Trans-radial Cardiac Catheterization

An interventional study of ulnar artery compression device and radial artery compression device guided with plysthmography in CARDIAC CATHETRIZATION, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-09.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Data from literature: transradial access failure sometimes occurs due to inability to cannulate the radial artery due to radial artery spasm1 causing severe difficulties in manipulation of the guide wires and catheters along the tortuous pathways of the arteries. both mechanical stimuli and circulating catecholamines through activation of α1-adrenoreceptors, causing smooth muscle cell contraction \& radial artery spasm

02

Conditions studied

  • CARDIAC CATHETRIZATION
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Normal radial artery and of size ≥ 2mm by duplex.
  • Normal ulnar artery by duplex.

Exclusion criteria

Exclusion Criteria:

  • Pre-procedural duplex detection of radial artery anomalies as hypoplasia, tortousity, severe calcification or radial artery diameter \< 2 mm.
  • Severe renal failure (creatinine clearance \< 30 ml/min).
  • Known peripheral vascular disease.
  • Emergency procedures.
  • Failure to successfully cannulate the radial artery was also a criterion for exclusion.
  • Patients on warfarin therapy.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    ULTRA method group

    Device: ulnar artery compression device · Device: radial artery compression device

  • Active comparator
    standard patent hemostasis group

    Device: radial artery compression device guided with plysthmography

  • Experimental
    control group

    Device: radial artery compression device

Interventions

  • Deviceulnar artery compression device

    a radial compression device will be applied at the access site. another closure device will be used for ipsilateral ulnar artery compression for 1-hour duration in order to increase peak velocity blood flow into the radi¬al artery. neither pulse oxymetry nor duplex ultrasonography will be performed in case of ulnar artery compression. after ulnar artery compression, the initial compression of the radial artery will be reduced by letting up the pressure until bleeding will be seen and then adding minimal pressure whenever needed in order to maintain radial artery patency.

  • Deviceradial artery compression device guided with plysthmography

    a radial compression device will be applied at the access site. A pulse oximeter sensor was placed over the index finger. Transient ipsilateral ulnar artery will be occluded manually to evaluate the status of radial artery patency by plethysmography (digital pulse analysis), and if there's lack of signal, the process of deflation and reinflation of the radial artery device's bladder will be repeated over the next 15 min to attempt re-establishment of antegrade radial artery flow without affecting hemostasis

  • Deviceradial artery compression device

    patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.

06

What researchers measure

Primary outcomes

  1. The percentage of occurrence of radial artery occlusion

    the assessment will be done after compression device removal guided by duplex post trans-radial cardiac catheterization.

    Time frame: 1 hour

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03182530
Lead sponsor
Assiut University
Responsible party
Eman Abbas Abdelaal (principal investigator, Assiut University) — Principal investigator
First posted
Jun 9, 2017
Start date
Jul 2017 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jun 9, 2017

Study contacts

Salwa dimitry, MD
Contact
salwademitry@yahoo.com
00201223971267
Magdy aldesowky, MD
Contact
magdyalgowhary@gmail.com
00201279950400
Tarek nagib, MD
principal investigator · Assiut University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion